POZEN is a dynamic company committed to building a portfolio of product candidates with significant commercial potential. At POZEN, we realize our success is based on the quality of our team. Our team’s success is a direct result of the quality and the experience of the individuals we employ. To apply for the positions shown below or to submit a resume, please contact us at Pozen is an equal opportunity employer.

Current Opportunities

Head of IT

POZEN is looking for a seasoned IT professional to lead this function and be responsible for the development, implementation, maintenance and strategic direction of the Information Technology function. This role influences the business direction in the design and execution of system solutions to support existing and new clients, products and operational complexities. Major priority include implementation of new ERP system as well as partnering with Commercial to develop and support key programs for field sales forces.The ideal candidate will possess a Bachelor’s degree plus advanced study in information technology and management with 10 years IT experience of increasing responsibility including prior project management, application development and infrastructure design. Five (5) years of pharmaceutical experience, inclusive of close collaboration with quality and regulatory to ensure compliance with FDA and other legal requirements preferred. Expert level knowledge of and proficiency with relevant hardware, software and database applications for the healthcare industry. Experience must include the selection, integration and implementation of related healthcare and general technology solutions.

Medical Science Liaison

We are looking to hire up to three (3) Medical Science Liaisons (MSLs) to be responsible for scientific exchange and developing relationships with Key Opinion Leaders (KOLS), investigators, institutions, groups, consortia, and other venues. The MSLs will participate in medical education for healthcare professionals on POZEN products, disease states of interest, and clinical research support. In addition to facilitating the identification of medical community training and educational needs for product introduction.Candidates for consideration will possess an advanced degree (M.D., Ph.D. or Pharm.D.) with prior experience in the pharmaceutical or healthcare education environment required. A minimum of 5 years cardiovascular experience is required. Clinical trial development experience is preferred. Ability to travel up to 50% of the time as this is a customer-facing position and the candidate’s availability for frequent travel is of paramount importance for professional and programmatic success.

GMP QA Manager/Sr. Manager – CMO/CTL Quality Oversight

As part of our operating model, we outsource all manufacturing and testing to CMO/CTL partners. As a result, we are looking for an experienced cGMP QA professional possessing experience with pharmaceutical manufacturing in solid dosage as well as the manufacture of API’s. They will be responsible for managing efforts to ensure compliance is maintained consistent with established Quality Agreements and also for manage compliance issues when the arise with our external manufacturing partners. This position will be based in the US reporting directly to the Site Director of Global Quality in Dublin, Ireland.

We are offering competitive salaries among other excellent benefits to the GMP QA manager that can ensure third party manufacturing operations meet our company’s high standards as well as remain FDA compliant.


  • Ensure GMP work is performed in compliance with applicable guidelines (e.g., CFR/ICH).
    Oversight and execution of Quality Assurance Processes (e.g. review/approval of deviations, performing site audits and for cause audits, batch record review)
  • Provide quality and compliance oversight of the quality systems and those of contract manufacturing and testing organizations.
  • Participate in the review, evaluation, qualification and approval of new contract manufacturing and testing facilities
  • Drafts and revises controlled documents.
  • Review/approve documents related to GMPs as requested and appropriate.
  • Coordinates activities for product batch record review and/or disposition of product.
  • Participate on project teams and lead sub-task groups as needed and assigned..
  • Track progress versus timelines and goals.
  • Ensure documents and records are kept in order.
  • Review relevant regulatory submissions as needed.
  • Audit Contractor and Suppliers for GMP compliance
  • Review and approve GMP documents and records
  • Review batch records and compile Product Disposition Packets and/or disposition of Company’s clinical products, API, drug product, and finished product.

Qualifications & Required Experience

  • Experience with small molecule/API and solid dosage manufacturing and Quality requirements
  • BA/BS or equivalent job-related experience
  • Knowledge, skills and experience required to act in the Quality role as it relates to GMP facilities, manufacturing, training, auditing, testing and quality assurance.
  • Working knowledge of cGMPs (CFR/ICH) and applicable international regulations and guidelines
  • Certified/Qualified cGMP Auditor preferred
  • Experience in maintaining Pharmaceutical Quality Systems
  • Experience with implementing Quality System Risk Management programs
  • Experience writing and presenting clearly on manufacturing and quality topics
  • 5-10 years’ experience in a GMP pharmaceutical or medical device industry in QA or related field
  • Experience collaborating within cross-functional teams internally and externally with CMO’s
  • Experience in oversight of outside vendors and contractors
  • Prefer some experience with clinical/commercial pharmaceutical programs

POZEN is an equal opportunity employer that rewards performance by providing an excellent compensation and benefits package, as well as equity participation and stimulating career opportunities.  Please submit a cover letter, resume and salary history in confidence to:

Human Resources
1414 Raleigh Road, Suite 400
Chapel Hill, NC  27517

No phone calls please