Director, GXP Audits and Inspections

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

Director, GXP Auditing and Inspections is responsible for development and continuous improvement of robust Global Clinical Management Systems. Laboratory, and PV auditing process, system and procedures. Responsible for auditing sponsor processes, trail master files, investigator sites, vendors (CROs, GLP Labs), pre clinical/GLP Study data ensuring quality activities are performed and documented in compliance with corporate policies, standards and all applicable global regulations with minimal supervisory oversight.

This position will develop and support strategic audit plans, executing GXP and PV audits, support vendor onboarding/qualification, and supplier quality activities for pre and post marketed products. This includes leading and supporting the development of risk assessments, audit programs, planning/resourcing audits, reporting, confirming suitability of CAPA, tracking/verifying CAPAs to completion. Oversight of Audit program through gathering and reporting audit metrics, findings, CAPAs and inspections at various Quality Governance forums and meetings. This role will host and lead health authority regulatory inspections for GLP, GCP, PV, GMP and GDP. Partner and lead cross functional business areas for inspection readiness activities, mock inspections, CAPA and post inspection/remediation. Other responsibilities include: Collaborate, review and approve cross functional and Quality Policies, SOPs/Training, Quality Events, CAPA/Effectiveness Checks and other Quality Documents.

Roles and Responsibilities

1. Lead and Management of Audits (GXP, PV and Supplier) internal systems/process and routine external vendor qualification audits. Determine Compliance status and identify compliance/quality risks. Analyzing and reporting trends in audit findings, as requested.

2. Lead/Support strategic development, maintenance and execution of risk-based audit schedule that will effectively monitor Amicus’ compliance with policies, procedures and applicable laws and regulations.

3. Evaluate the impact of audit findings, authors audit reports, provides guidance and root cause analysis. This also includes oversight, review, and approval of other team members audit reports.

4. Provides guidance on the development of CAPA responses, reviews responsibilities for suitability and tracks CAPA commitments to completion. Conducts CAPA verification.

5. Lead and Support pre and post market Regulatory Inspections as host and front room lead facilitating inspection. Facilitates development of responses to inspection findings, develops and oversees implementation of CAPA plans. Report CAPA metrics and provides periodic reports to management.

6. Lead and support Quality Improvement initiatives and Quality projects as assigned.

7. Partner with cross functional business areas on SOPs/training, Quality Events/CAPAs, Effectiveness Checks and other quality documentation. Review and approve documentation for Quality.

8. Lead and facilitate quality meetings which includes facilitation, agendas, slide creation, presenting and meeting minutes. Represent QA at various cross functional meetings/forums.

9. Develop, coach and train cross functional team members/auditors as needed to support audits.

Requirements

Educational Requirements

• Minimum of Bachelor’s Degree or equivalent experience in life sciences, or nursing or extensive equivalent experience necessary to fulfill position requirements.

• BA/BS degree with 10-12 years experience

• Masters degree with 7-10 years experience

Professional Work Experience Requirements

• Minimum of either (8) years’ experience in the pharmaceutical/CRO industries, within Assurance Function. This includes GCP/GLP and Part 11 auditing experience as it relates to Sponsor, site, central lab and vendor audits required.

• Pre Approval Inspection Readiness Audit experience required. Must have GXP auditing and health authority regulatory inspection experience at a global level.

• Experienced in audit report preparation and managing CAPA 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 regard to audit reports, policies and procedures.

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

Experience and Skills

• Strong written and verbal communication, analytical problem solving and conflict resolution skills.

• Must be able to communicate professionally, influence and educate 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 QMS/Document Management system such as Trackwise Digital and/or Veeva is preferred.

Other skills/Attributes

• Demonstrated alignment with Amicus Mission Focus Behaviors

• Passion for rare disease and patient focused

Travel

• Ability to travel domestically and internationally up to 25%

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.

Job Type: Full-time

Pay: $200,000.00 - $210,000.00 per year

Benefits:

• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus opportunities

Experience:

• GCP: 5 years (Required)

Work Location: Hybrid remote in Princeton, NJ 08542