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Job Function:
Legal & ComplianceJob Sub Function:
Enterprise ComplianceJob Category:
ProfessionalAll Job Posting Locations:
Leiden, South Holland, Netherlands, Sassenheim, NetherlandsJob Description:
Compliance Manager
Location: Leiden, South Holand, Netherlands
Contract: Full Time
Overall, Purpose of this Job:
Accountable for the site internal quality program and external GMP audit and inspection readiness and management programs. Prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, Corporate, etc.). Provide compliance subject matter expertise to the manufacturing sites and site based projects. Deploy compliance initiatives for the site in alignment with Innovative Medicine Regulatory Compliance.
The responsibilities & the impact YOU will have:
- Lead and complete internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
- Organize and complete compliance walk-throughs (e.g. GEMBA)
- Evaluate responses to internal audits
- Enter internal audit data into quality system
Support external GMP audits and inspections (Health Authority, Customer). Including:
- Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
- Partner with Quality to manage inspections (host and/or coordinate front room and back room, issue daily inspection summaries)
- Prepare/review site responses and associated CAPA for Health Authority/Customer inspections
- Identify changes in regulations that impact compliance procedure, perform comparisons against current practices.
Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
May represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.
Partner with site for execution of proactive compliance scans.
Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc.) to proactively identify risks and drive compliance improvement across the site.
Other Duties:
- Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards
- As needed, co-authors, review, and revise compliance procedures.
- As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions
- Conduct Mock Recalls
We’d love to hear from YOU, if you have:
- Bachelor’s degree in science or related field
- At least 7 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience.
- Knowledge of global GMP and ATMP regulations is required.
- Preferred experience and knowledge of/with Large Molecule and/or Advanced Therapies.
- Strong analytical skills. Ability to clearly articulate issues.
- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance communities.
- Delivers on commitment timelines and has high sense of urgency.
- Experience performing internal or external audits of GMP regulated facilities.
Travel Requirements:
- Domestic travel is possible
- Approximately 10-15% travel.
Preferred Qualifications:
- QA/RA certification is preferred.
- (Lead) Auditor Certification
- Applicable regulations (GMP, ATMP, etc.)
Compliance Lead
Location: Leiden, South Holand, Netherlands
Contract: Full Time
Overall, Purpose of this Job:
Accountable for the site internal quality program and external GMP audit and inspection readiness and management programs. Prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, Corporate, etc.). Provide compliance subject matter expertise to the manufacturing sites and site based projects. Deploy compliance initiatives for the site in alignment with Innovative Medicine Regulatory Compliance.
The responsibilities & the impact YOU will have:
- Lead and complete internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
- Organize and complete compliance walk-throughs (e.g. GEMBA)
- Evaluate responses to internal audits
- Enter internal audit data into quality system
Support external GMP audits and inspections (Health Authority, Customer). Including:
- Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching)
- Partner with Quality to manage inspections (host and/or coordinate front room and back room, issue daily inspection summaries)
- Prepare/review site responses and associated CAPA for Health Authority/Customer inspections
- Identify changes in regulations that impact compliance procedure, perform comparisons against current practices.
Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
May represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.
Partner with site for execution of proactive compliance scans.
Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc.) to proactively identify risks and drive compliance improvement across the site.
Other Duties:
- Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards
- As needed, co-authors, review, and revise compliance procedures.
- As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions
- Conduct Mock Recalls
We’d love to hear from YOU, if you have:
- Bachelor’s degree in science or related field
- At least 7 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience.
- Knowledge of global GMP and ATMP regulations is required.
- Preferred experience and knowledge of/with Large Molecule and/or Advanced Therapies.
- Strong analytical skills. Ability to clearly articulate issues.
- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance communities.
- Delivers on commitment timelines and has high sense of urgency.
- Experience performing internal or external audits of GMP regulated facilities.
Travel Requirements:
- Domestic travel is possible
- Approximately 10-15% travel.
Preferred Qualifications:
- QA/RA certification is preferred.
- (Lead) Auditor Certification
- Applicable regulations (GMP, ATMP, etc.)