Position Description

Associate Director, Quality Assurance GCP (Preferred location Princeton, NJ)
Location United States
Requisition ID 1892
# of openings 1
Apply Now

Associate Director, Quality Assurance GCP

SUMMARY OF POSITION

The Associate Director, Clinical Quality Assurance is responsible for all aspects of Quality Assurance activities for Good Clinical Practice (GCP).  This includes development of audit plans, planning and conducting audits, issuing audit reports, confirming suitability of corrective actions, preventive action plans (CAPAs), verifying and tracking CAPAs to completion and keeping management informed of associated metrics.  In addition, this role leads to helps prepare Amicus for GCP regulatory inspections.  Other responsibilities include provision of regulatory compliance and QA guidance to clinical teams, reviews and provides QA input on clinical QMS related policies/procedures and leads training efforts for SOP and regulatory topics in the scope of responsibilities based on needs analysis.

MAJOR ACTIVITIES AND RESPONSIBILITIES

The Associate Director, Clinical Quality Assurance is responsible for:

•            Lead and/or Management Audits (GCP)

•            Manage and/or participate in audits, including, but not limited to, internal process audits, internal mock inspection, external vendor audits and clinical site audits, determine compliance status and identify compliance risks.

•            Contributes to the risk-based audit schedule that will effectively monitor Amicus’ compliance with policies/procedures and applicable laws and regulations.

•            Evaluates the impact of audit findings and authors (or oversees production of) audit reports, provides guidance on root cause analysis.

•            Provides guidance to clinical teams on adequate development of corrective actions responses, reviews responses for suitability and tracks CAPA commitments to completion.

•            Conducts CAPA and Effectiveness Check verification in electronic system.

•            Provides management with updates on completion status and produces audit metrics for Quality oversight committees and senior management.

•            Facilitates ongoing quality improvement measures through communications of audit results and compliance guidance/training.

•            Support Pre-and Post-Market Regulatory Inspections

•            Prepares the Company and clinical sites for regulatory inspections.

•            Participates on inspection teams and hosts inspection as necessary.

•            Facilitates development of responses to inspection findings, develops and oversees implementation of related CAPA plans.

•            Conducts or oversees CAPA verification audits and creation of verification binders.

•            General QA Duties (including but not limited to)

•            Author, review and approved GCP related policies and procedures.

•            Lead or support as needed the QA team with regards to SOP and regulatory training needs.

•            Quality meetings:  Coordinate QA meetings including but not limited to creating agendas, management invitations, collation of slides and generation and distribution of meeting minutes.

•            Support the conduct and reporting of GCP non-compliance investigations.

•            Support clinical vendor qualification needs as requested.

•            Represent QA at Company meetings as needed.

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements

•            BA/BS degree with 8-10 years of experience

•            Master degree with 7-10 years experience

•            PhD degree with 5-7 years experience.

Professional Work Experience

•            Minimum of either (6) years experience in the pharmaceutical/CRO industries, within Quality Assurance function.

•            Must have solid GCP auditing/inspection experience at a global level. GLP and CFR Part 11 auditing experience preferred but not essential.  Experienced in audit report preparation and managing CA development.  Vendor qualification and experience with audit bioanalytical labs a plus.

•            Experienced in quality metrics creation, reporting and analysis as well as process improvement techniques.  Objective writing skills with regards to audit reports, policies and procedures.

•            Demonstrated knowledge in the regulatory areas of importance to Amicus (e.g., FDA/EU Regulations, 21 CFR Part 11, ICH-GCP, HIPAA/data privacy).

•            Strong written and verbal communication, analytical, problem solving and conflict resolution skills.  Must be able to communicate professionally at all levels of the organization.

•            Flexible, highly motivated, with strong organizational skills and the ability to multi-task.  Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment.

•            Leading a team and develop of direct reports is preferred.

•            Project Management experience preferred.

•            Experience in management people and/or with in on cross functional teams.

Location

  • Preferred location is Princeton, NJ (with a hybrid work approach)
  • It is expected that any remote workers are able to travel to the office up to 10% of the time

 

 

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.  Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence.  Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.

 

#LI-Remote

Back Apply Now