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Manager, Clinical Quality Assurance - Clinical - Bridgewater, NJ


Position Overview

The Manager, Clinical Quality Assurance is a key member of the Osmotica Research and Development organization. This role is responsible for Clinical QA activity related to the planning, conduct, and reporting of GCP audits in order to ensure that clinical studies are conducted in compliance with applicable regulations, guidelines and company standards. This role also has responsibility for preparation, management, and follow-up of GCP inspections as well as ongoing quality oversight and consultation on clinical studies. This individual actively evaluates and applies audit/inspection outcome learnings and trends to support improvement in clinical trial quality and compliance with company and regulatory requirements. Responsibilities also include leading and/or contributing to identification, development, implementation, management, and enhancement of R&D Quality operational processes, systems, tools and best practices.

Duties and Responsibilities

  • Plan, manage and perform GCP audits of Contract Research Organizations (CROs), systems/processes and clinical Investigator sites for Phase 1 to 4 clinical trials
  • Prepare audit reports and communicate findings to auditees, study team representatives and management
  • Review and assess audit report responses and ensure that corrective and preventative action (CAPA) plans adequately address findings and root cause analysis
  • Evaluate, track and follow up on CAPAs to ensure actions are adequately completed in a timely manner
  • Lead and/or participate in the planning, conduct and follow-up of Regulatory GCP inspections
  • Assess inspection readiness and contribute to development and delivery of Inspection Readiness training for cross-functional team members, as needed
  • Contribute to assessment of reports and results from Regulatory Inspections
  • Assist in preparation of response documents for Site Inspections and Sponsor/CRO Inspections
  • Lead efforts for completion of inspection follow-up activities
  • Participate in regular study team meetings and provide quality oversight and consultation at program/study level
  • Maintain ongoing awareness of program and study issues related to quality, safety and efficacy
  • Provide risk identification/mitigation support for potential and/or identified quality issues
  • Evaluate audit/inspection trends and other information sources to support audit planning and optimize clinical trial quality and compliance
  • Provide GCP compliance consultation on process enhancement/compliance and quality issue management
  • Appropriately escalate quality/compliance issues to management
  • Maintain current industry knowledge of applicable regulations, guidelines, and company standards
  • Evaluate impact of new regulations/guidance, as well as audit results/trends on the business and regulatory risks and provide guidance
  • Contribute to the identification and communication of lessons learned from audits and inspections
  • Travel as needed, up to 30% domestic and internationally

Experience and Qualifications

  • BA/BS degree in relevant discipline or equivalent/relevant work experience required
  • At least 5 years of experience in clinical research and/or a GCP-related environment, with at least 3 years of clinical quality assurance auditing required
  • Extensive working knowledge of international regulations, guidelines and good practices pertaining to clinical trials required
  • Good working knowledge of standard computer office software such as Word, Email system (Outlook), PowerPoint and Excel
  • Strong analytical abilities and attention to detail
  • Ability to work both independently as well as in a team environment
  • Strong organizational and time management skills
  • Ability to prioritize and multi-task successfully in a fast-paced environment
  • Flexibility to manage shifting demands and changing priorities, proactively looking for ways to contribute
  • Excellent verbal and written communication skills including ability to clearly articulate information and interact effectively with cross-functional team members
  • Demonstrates critical thinking, sound judgement, and initiative to solve problems
  • Ability to perform all essential functions of the position, with or without reasonable accommodation

About Us

Osmotica Pharmaceuticals is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products using a proprietary osmotic technology platform.  In February 2016, Osmotica Pharmaceuticals combined with Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC to create a world-class, fully-integrated specialty pharmaceutical and generics company.

Vertical Pharmaceuticals, LLC was founded in 2003 with a mission to develop, market, and acquire products offering therapeutic benefits for patients and healthcare providers. Vertical Pharmaceuticals supplies branded prescription products, specializing in Neuroscience and Women’s Health with brands such as Lorzone®, Divigel®, and OB Complete®.

Trigen Laboratories, LLC is a generic pharmaceutical company offering unique products across an increasing array of categories. Trigen seeks to bring value-driven generic products to its customers, working vigorously with its partners to identify and develop products which face an assortment of challenges. Additionally, Trigen identifies unique marketing opportunities and is steadfast in its pursuit to deliver products to best serve these markets.

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability or veteran status.



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Brian Markison, Chairman of the Board and Chief Executive Officer

Brian Markison has served as Chairman of the Board and Chief Executive Officer of Osmotica since 2016. Mr. Markison is a healthcare industry veteran, with more than 30 years of operational, marketing, commercial development and sales experience with international pharmaceutical companies. He has served as an advisor to Avista Capital Partners since September 2012. He previously served as the President, Chief Executive Officer and board member of Fougera Pharmaceuticals, Inc., a dermatology-focused specialty pharmaceutical company sold to Sandoz Ltd., the generics division of Novartis AG. Before leading Fougera, Mr. Markison was Chairman and Chief Executive Officer of King Pharmaceuticals, Inc., which he joined as Chief Operating Officer in March 2004. He was promoted to President and Chief Executive Officer later that year and elected Chairman in 2007. Prior to joining King Pharmaceuticals, Inc., Mr. Markison held various senior leadership positions at Bristol-Myers Squibb. He serves as Chairman of the Board of Lantheus Holdings, Inc. and is on the board of directors of Avista Healthcare Public Acquisition Corp., National Spine and Pain Centers, LLC and Braeburn Pharmaceuticals, Inc. He is also a Director of the College of New Jersey.

James Schaub, Executive Vice President and Chief Operating Officer

James Schaub has served as our Executive Vice President and Chief Operating Officer since 2016. Mr. Schaub previously served as Chief Operating Officer of Trigen Laboratories and as Vice President of M&A at Fougera Pharmaceuticals, Inc. He also held several commercial roles of increasing responsibility at King Pharmaceuticals, Inc. Mr. Schaub is a graduate of Middlebury College and holds an M.B.A. from Rutgers Business School.

Andrew Einhorn, Chief Financial Officer

Andrew Einhorn joined as Chief Financial Officer in September 2017. Mr. Einhorn has more than 15 years of experience in the pharmaceutical industry. Mr. Einhorn previously served as the Chief Financial Officer of Edge Therapeutics, Inc., a clinical-stage biotechnology company that he joined as Executive Vice President of Corporate Development in 2013. Prior to that, he was a co-founder, Executive Vice President and Chief Financial Officer at Oceana Therapeutics, Inc. Previously, Mr. Einhorn was a co-founder and Chief Financial Officer of both Esprit Pharma, Inc. and ESP Pharma, Inc. Mr. Einhorn is licensed as a Certified Public Accountant in the State of New Jersey and holds a B.S. in Finance and Accounting from American University.

Christopher Klein, J.D., General Counsel and Secretary

Christopher Klein has served as our General Counsel and Secretary since December 2013. Mr. Klein previously served as the General Counsel of Fougera Pharmaceuticals, Inc. and as Deputy General Counsel at King Pharmaceuticals, Inc. Mr. Klein spent six years in senior legal roles with Bristol-Myers Squibb Company. Mr. Klein holds a B.A. in Biology from Adelphi University, an M.A. in Education from Columbia University and a J.D. from Fordham University.

Tina deVries, Ph.D., Executive Vice President, Research and Development

Tina deVries, Ph.D. became our Executive Vice President, Research & Development in May 2016. Dr. deVries most recently served as the Principal of TM deVries Consulting, LLC. She was previously Vice President of Nonclinical and Clinical Pharmacology at Actavis plc following its 2013 acquisition of Warner Chilcott plc where she served as the Vice President of Clinical Pharmacology. Dr. deVries holds a B.S. in Pharmacy and a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from Ohio State University.

Lynn Franklin Palmer, Senior Vice President, Technical Operations

Lynn Palmer has served as our Senior Vice-President, Technical Operations since June 2017. Prior to that, he served as Vice-President, Manufacturing from February of 2016. Before Osmotica, Mr. Palmer served as Executive-Vice-President, Engineering at King Pharmaceuticals for six years. Previously Mr. Palmer led Engineering at Mallinckrodt Inc. (a division of Tyco Healthcare), and served as Vice-President, Production at Inbrand Corporation. Prior to Inbrand, he served in progressive manufacturing management roles at Kimberly-Clark Corporation from 1982-1996. Mr. Palmer holds a Bachelor of Applied Science in Paper Science and Engineering from Miami University.

Jarret Miller, Executive Vice President, Human Resources

Jarret Miller has served as our Executive Vice President, Human Resources since January 2016. Mr. Miller has more than 20 years of Human Resources experience in various roles of increasing responsibility. He previously served as the Head of Human Resources Operations and Services for the Americas at Teva Pharmaceuticals, Inc. Prior to that, he held the positions of Vice President, Human Resources at ConvaTec, Inc. and Senior Vice President, Human Resources at King Pharmaceuticals, Inc. Mr. Miller holds a B.S. in Statistics and Biometry from Cornell University.

David Burgstahler

David Burgstahler has been a director since 2016. Mr. Burgstahler is the President and Co-Managing Partner of Avista Capital Partners and is the Chief Executive Officer of Avista Healthcare Public Acquisition Corp. Mr. Burgstahler was a founding partner of Avista Capital Partners in 2005 and since 2009, has been President of Avista Capital Partners. Prior to forming Avista Capital Partners, Mr. Burgstahler was a partner of DLJ Merchant Banking Partners. Previously, Mr. Burgstahler worked at Andersen Consulting (now known as Accenture plc) and McDonnell Douglas (now known as The Boeing Company). Mr. Burgstahler currently serves as a director of Avista Healthcare Public Acquisition Corp., Inform Diagnostics, Inc., Kramer Laboratories, Inc., United BioSource Corporation and WideOpenWest, Inc. He is also a Trustee of the Trinity School in New York City. Mr. Burgstahler holds a B.S. in Aerospace Engineering from the University of Kansas and an M.B.A. from Harvard Business School.

Sriram Venkataraman

Sriram Venkataraman has been a director since 2016. He is a Partner of Avista Capital Partners, having joined in 2007. Prior to joining Avista Capital Partners, Mr. Venkataraman was a Vice President in the Healthcare Investment Banking group at Credit Suisse Group AG. Previously, he worked at GE Healthcare (formerly known as GE Medical Systems). He currently serves as a director of OptiNose, Inc., Inform Diagnostics, Inc. and National Spine & Pain Centers Holdings, LLC and previously served as a director of AngioDynamics, Inc., Lantheus Holdings, Inc. and Zest Anchors, Inc. Mr. Venkataraman holds an M.S. in Electrical Engineering from the University of Illinois, Urbana-Champaign and an M.B.A. from The Wharton School at the University of Pennsylvania.

Daniel Sielecki

Daniel Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki has worked at Laboratorios Phoenix S.A since 1975 and currently serves as a director of Simali S.A., Petroquımica Cuyo S.A and PEPCA S.A. He previously served as a director of Disprofarma S.A.

Carlos Sielecki

Carlos Sielecki became a director of Osmotica Holdings Corp Ltd. in 2007 and joined the board of directors in 2016 in connection with the combination of Osmotica Holdings Corp Ltd. and Vertical/Trigen. Mr. Sielecki currently serves as a director of Simali S.A. and holds a degree in architecture from the University of Buenos Aires.

Juan Vergez

Juan Vergez became a director in 2016. Mr. Vergez served as the President of Osmotica Argentina from November 2010 to May 2016, and as the New Business Director of Osmotica Argentina from May 2016 to December 2017. Mr. Vergez previously served as a director of Nutrifoods, S.A. and has more than 40 years of experience in the pharmaceutical industry.

Sergio Alegre

Sergio Alegre became our Vice President of Global Compliance in August of 2016. Mr. Alegre previously served as Executive Director of Pacira Pharmaceuticals, Inc., where he implemented and oversaw its Compliance Program from August 2012 to August 2016. In addition, he spent seven years as Vice President of Mergers and Acquisitions for Realogy Corporation, following a time in private practice at a law firm in New York City. He holds a B.A. in Political Science and History from Rutgers University and a J.D. from Fordham University School of Law.