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Quality

Compliance Manager

  • 标题 Compliance Manager
  • 功能 Quality
  • 子功能 Compliance
  • 工作地 Ghent, East Flanders, Belgium
  • 发布时间
  • 申请ID 2306144715W
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描述

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.   

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.  

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.   

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!  

Become part of a new organization! Own the internal audit program at the Belgium CAR-T Pharmaceutical manufacturing sites. Prepare for and support external GMP/ATMP audits and inspections. Provide compliance subject matter expertise to the manufacturing sites and site-based projects.

Major Responsibilities:

  • 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.

资格

Required Qualifications:

  • 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 Advanced Therapies and/or CAR-T.
  • 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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