Senior Regulatory Compliance Specialist
2 weeks ago
**Job Description:**
- Support the strategic development of an effective global risk-based audit strategy and program; collect, collate, and incorporate input into audit strategy and plan.
- Lead, plan, conduct, document, and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the respective Quality Module as well as applicable regulations, standards, quality agreements, and guidance documents. Perform activities with a high degree of independence.
- Provide technical guidance, leadership, mentoring, and training of other Auditors on audit-related activities. Prepare audit reports, according to required timelines.
- Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to Management Escalations and other relevant procedures. Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
- Identify and communicate quality and regulatory compliance issues to quality management through appropriate channels as well as recommend remediations. Lead compliance investigations and initiatives focused on inspection readiness and quality, process, and compliance improvement as requested.
- Support mock pre-approval inspections (PAIs) and Health Authority inspections as needed. Proactively research local and global initiatives, trends, and events that impact the maintenance of compliance. Mentor clinical staff as required. Complete any other request from Global Audit.
- **Essential Requirements:**
- 15+ years of proven experience in GCP / GPvP / clinical / industry / health authority experience or equivalent.
- 8+ years of GCP/PV auditing experience preferred and willingness to travel up to 60% of the time.
- Ability to lead and objectively evaluate compliance issues. Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision-making and problem-solving.
- Experience with Health Authority inspections and interactions preferred. Good quality and compliance leadership and facilitation skills.
- Excellent verbal and written communication, organizational, and interpersonal skills. Excellent computer skills including Excel, MS Office, etc.
- Extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures. Good knowledge of CSV and 21 CFR Part 11, ability to lead audit teams, and operate successfully in various team capacities.
- Excellent leadership and facilitation skills, Auditor certification desirable.
- **Desirable Requirements:**
- Graduate in natural/biological sciences or equivalent, or an equivalent mix of education and experience
**Skills Desired:
Agility, Auditing, Audit Management, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Compliance Audits, Continuous Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness, Leadership, Logical Thinking, Major Incident Management, Organization Skills, People Management, Problem Solving Skill, Problem Solving Skills + 5 more
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