Chief Executive Officer

e.porcelli@rcainc.com

As CEO of Regulatory Compliance Associates®️ Inc., the number one focus for Erika Porcelli is customer experience. Coming from a background that has touched all aspects of RCA services, Erika Porcelli values the importance of client relations above all.

In her time with RCA, Erika has developed strategies to increase average project revenue by helping the company attract larger, targeted projects while also nurturing the pipeline with smaller ones, for both new and existing accounts. With her she brings extensive knowledge in marketing programs, analysis and market research, marketing communications, and sales process opportunities including identifying potential projects, proposal development, and project awards.

Erika maintains current relationships and pursues new opportunities with her expanding connections to quality, regulatory, and research & development management throughout the life science industry. She provides support to all organizational sizes from small startups to multinational corporations.

Energetic and results-oriented, Erika was formerly the Senior Director of Business Development for RCA’s northern U.S. territory and, most recently, Vice President of Client relations—before her promotion to CEO. With more than 15 years’ experience in relationship building and key account management, Erika’s other areas of expertise include new business development, contract negotiation and administration, and budget management.

Erika resides in Woodbury, Connecticut and is a frequent visitor to the RCA offices in Pleasant Prairie and Tampa.

 

About RCA

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Chief Financial Officer

b.matye@rcainc.com

Brian Matye has a career that includes more than 25 years in senior engineering leadership roles at Baxter Healthcare Corporation, GE Healthcare, and Medtronic, with experience in all phases of high-reliability systems, medical product development, and systems deployment.

Brian came to Regulatory Compliance Associates®️ Inc. in 2010 as General Manager of RCA’s Southeast Regional office in Tampa, leading the firm’s business development functions as well as providing consulting services in the areas of quality, engineering, and regulatory compliance for medical device clients.

As Chief Financial Officer, Brian possesses executive-level experience in all phases of life science product development and product release. A highly skilled problem solver with excellent interpersonal skills, his areas of expertise encompass business development, P&L creation and management, inter-departmental coordination, process definition, and quality assurance.

Brian’s depth of knowledge includes medical device, quality systems, and pharmaceutical development regulations. His innate ability to turn customer concerns into actionable engagements, as well as maintain good client interactions, is key to RCA’s success. He is based in the Tampa office and travels frequently to RCA’s Wisconsin headquarters in Pleasant Prairie and to client meetings around the country. Brian graduated from the University of Wisconsin–Superior with a Bachelor of Science in Mathematics and earned his Master of Business Administration in Operations from the University of Minnesota. He lives in Odessa, Florida.

 

About RCA

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Executive VP of Medical Device and CTO

s.khorashahi@rcainc.com

Seyed Khorashahi has more than 25 years’ experience leading R&D teams in all aspects of developing safety-critical medical devices. He has held leadership positions at Covidien (Medtronic), Baxter, and Beckman Coulter, Inc., and has an extensive background in medical device product development, quality systems, regulatory affairs, and mergers and acquisitions. Other core competencies include engineering and business strategy.

Returning to Regulatory Compliance Associates® Inc. in 2015 as COO, he works in conjunction with the CEO and the Board of Directors to define operational and technical strategy for RCA, as well as plan and develop the primary processes that support the delivery of RCA client services.

Seyed has significant domain expertise not only in FDA and EU standards but also in software systems and hardware development for medical devices. A passionate innovator, he is a skilled collaborator as well, with recognized leadership capabilities and a relentless drive to overcome technical and business challenges. He is an influencer, consensus-builder, and a leader with success in establishing and managing relationships with external partners, executives, and internal multi-functional teams.

In addition, Seyed is adept at using strong analytical and technical skills to lead teams in solving complex problems and fulfilling the voice of the customer. He has a proven track record of efficiently deploying process improvements with extensive knowledge of 21 CFR 820 and ISO 13485.

Previously, Seyed served as a Director, R&D with Covidien. Prior to Covidien, he was RCA’s Director of Software Systems where he led teams to perform technical due diligence projects and for multiple implementations of medical device quality systems compliant with ISO 13485 and FDA Quality System Regulation (QSR). He was also responsible for design history file remediation for legacy products and led the assessments of product development to identify technical and regulatory gaps and recommended solutions.

Seyed earned a Bachelor of Science in Electrical Engineering and a Master of Science in Computer Science from Florida International University in Miami, Florida. Seyed lives near Boulder, Colorado but makes frequent trips to the Pleasant Prairie and Tampa offices.

 

About RCA

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Executive VP, Pharmaceuticals

s.lynn@rcainc.com

Steve Lynn has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues.

Joining Regulatory Compliance Associates® Inc. in September of 2020, Steve serves as RCA's Executive Vice President of Pharmaceuticals. 

Prior to joining RCA, Steve Lynn served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multi-national corporations and also worked as a consultant for multiple large, mid-sized, and small clients. He was the Global Head of Group (Corporate) Compliance and Audit for Novartis AG. In this role he led the corporate-level GxP corporate compliance and audit functions across the company. Next, Steve was the inaugural Vice President of Global Quality Compliance for Mylan, Inc. a large generics manufacturer.

Prior to rejoining the private sector, Steve worked for nearly a decade at the FDA. At the FDA, was the Director of the FDA/Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role, he was responsible for the global Current Good Manufacturing Practices (CGMP) oversight of all drugs manufactured and/or imported into the United States to assure compliance with CGMPs. In addition, in his last year at the FDA, he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality (OPQ) reporting to CDER’s Center Director where he was responsible for setting up OPQ operations.

Steve also served in two acting roles on the inspectorate side of FDA within the Office of Regulatory Affairs (ORA). First, he served as the acting Senior Advisor to the Assistant Commissioner for Operations (ACO) within the Immediate Office of ORA’s Office of Operations. In this role, Steve was responsible for advising the ACO in their role of leading and managing ORA's Office of Operations, which is responsible for all of the Agency's Headquarters, Domestic and Foreign Field Investigatory, Compliance, and Laboratory Operations.

Second, Steve served as the acting Director for ORA’s Office of Medical Products and Tobacco Operations (OMPTO). In this role, Steve represented and made decisions on behalf of the ACO relating to medical and tobacco product program investigatory operational issues, including emergency response activities. In addition, he directed the coordination and management of all domestic and foreign Agency field operations related to medical (drugs, biologics, and medical devices) and tobacco products and served as the operational liaison for medical products and tobacco inspection programs to FDA’s medical product and tobacco Centers, as well as to the Agency’s foreign offices.

Steve received a Bachelor of Science degree in Biology from Bethany College in Bethany, WV, and a Master of Science Degree in Quality Systems Management from the National Graduate School in Falmouth, MA. He is an Eagle Scout, Senior Member of the American Society for Quality (ASQ), and an Excellence in Government Program Senior Fellow.

 

About RCA

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

VP, Marketing and Business Development

j.semmler@rcainc.com

Joby Semmler is an integrity-based leader with over 25 years of experience leading & inspiring teams during business development, marketing, commercialization & product management initiatives.

As Vice President of Marketing and Business Development for Regulatory Compliance Associates® Inc., Joby leads revenue generation and customer acquisition by developing and executing comprehensive sales and marketing plans covering all aspects of the business development model including branding, sales cycle management, client account management, and customer experience.

Joby began his career in outside sales, including pharmaceutical sales for a division of Pfizer (thiazolidinedione, SSRI, statins). As his career transitioned to marketing, Joby led direct-to-physician marketing programs for healthcare client Eli Lilly (Zyprexa, Cymbalta, Straterra, Symbyax, Prozac, Cialis). Joby was also a neuroscience Brand Manager for the largest healthcare system in Indiana (Indiana University Health) and led the marketing team for the largest clinical engineering firm in the United States (TriMedx). Before joining RCA, Joby led the global marketing team for the first HIPAA-approved Telehealth electronic health records software company (Opus EHR).

Joby is a curious solution provider with the emotional intelligence and professional experience to thrive in a fast-paced, global matrix environment making him a prime example of how we do business here at RCA.

Joby has a Master of Business Administration from Butler University in Indianapolis, Indiana. As well as a Bachelor of Science in Marketing and Economics Minor from Indiana University in Bloomington, Indiana.

 

About RCA

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

RCA Distinguished Fellow

s.schniepp@rcainc.com

Susan Schniepp is the knowledge leader for Regulatory Compliance Associates® Inc. and is responsible for training and advising RCA staff and clients on current trends and issues facing the pharmaceutical, biotechnology, and medical device industries. Her background includes cGMPs, audit readiness, change control, investigations, supplier quality, and batch record review.

Sue has more than 40 years’ experience in quality assurance, serving in leadership roles at Allergy Laboratories, Inc.; Oso BioPharmaceuticals LLC; Searle; Abbott; and Hospira. She has been on the Parenteral Drug Association (PDA) Board of Directors from 2011- 2013 and from 2016- 2019 and currently serves as the Chair-Elect. Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002.

Her publications include the book Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process for which she was awarded the 2007 PDA's Distinguished Author Award. Sue also co-edited and contributed to the book Pharmaceutical Outsourcing: Quality Management and Project Delivery.

Since 2007, she has served as a columnist and member of the editorial advisory board for Pharmaceutical Technology Magazine and was also Chair of a USP Monograph Development Expert Committee from 2005-2010.

The recipient of numerous PDA and USP Awards and Acknowledgements, Sue remains prolific in the industry through podcasts, videocasts, presentations, and webinars.

Sue holds a Bachelor of Science in Biology from Northern Illinois University in DeKalb, Illinois. She lives in Albuquerque, New Mexico, but sees the world on behalf of RCA.

 

About RCA

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Controller

k.kurth@rcainc.com

Krista Kurth has more than 20 years’ experience in accounting and project management. She joined Regulatory Compliance Associates® Inc. as the Director of Accounting in 2012 and was promoted to Controller in November 2016.

As Controller, Krista Kurth oversees the accounting department, maintains financial records, develops relevant procedures, and prepares financial statements. In addition, she provides operational and financial reporting.

A collaborative leader with proven ability to build and develop highly effective teams, Krista is known for her attention to detail, commitment to quality, and the ability to work well on all levels.

Prior to joining RCA, Krista spent 14 years at Jet Support Services, Inc. in Chicago, Illinois, most recently as its Director of Plans & Controls.

She holds a Bachelor of Science in Marketing from DePaul University and has passed the CPA exam. From her Kenosha, Wisconsin home, Krista has a quick commute to the Pleasant Prairie office.

 

About RCA

 

pharmaceutical consultantsRegulatory Compliance Associates® (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory challenges:

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

News

Parenteral Products Sterilization and Extractables Evaluation to Help Ensure Drug Safety...
Read More

News

Parenteral Products Sterilization and Extractables Evaluation to Help Ensure Drug Safety...
Read More

News

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue