Sr. Compliance Specialist

Essential Job Duties and Responsibilities

Execute internal audit program at the Pharmaceutical manufacturing sites. Prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc). Provide compliance subject matter expertise to the manufacturing sites and site based projects. Deploy compliance initiatives for the site in alignment with Pharmaceutical Regulatory Compliance.

Site internal audit program:

• Execute internal audits (schedule, issue agenda, prepare, conduct audit, issue report)

• Execute compliance walk-throughs (e.g. GEMBA)

• Evaluate responses to internal audits

• Enter internal audit data in to COMET

Facilitate and/or 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, daily inspection summaries)

• Review site response and associated CAPA for Health Authority inspections

• Provide input to daily inspection summaries, as needed

Support identification of changes in regulations and gap assessments related to compliance procedures:

• Identify changes in regulations that impact compliance procedure, perform gap analysis against current practices.

• Implement J&J Compliance Stds (e.g. Audit/Inspection Mgt) and partner with sites on J&J standard implementation (Sr.)

Participate on project teams, as requested:

• Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.

• Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance mtgs, etc.

• Partner with site for execution of proactive compliance scans.

• Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Mgt, etc) to proactively identify risks and drive compliance improvement across the site

Regulatory compliance documentation and remediation plans

• Receive regulatory compliance requests, reviews and provide applicable documentation to accurately address the request and deliver documents to the requested in the agreed due date.

• Track regulatory requests until final completion and closure.

• Prepares GMP statements and responses to questionnaires for the facility or applicable product, as required.

• Assures regulatory documents are archived.

• Support organization in preparation compliance metrics, dashboards, preparation of Site Mgt reviews, etc.

• As applicable, monitor progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc) (Sr.)

• Collaborate with other groups in PRC and JJRC to support execution of independent audits and special assessments. Support site during ERC audits (e.g. document review, front/back room support). Review and provide input to site response, and associated CAPA, to ERC audits (Sr.)

• Ensure timely and accurate reporting of compliance metrics (Sr.)

• Coordinate compliance training for the site (Sr.)

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

Domestic travel is possible (10-15%).

The anticipated base pay range for this position is 62.600 Euro to 100.970 Euro on an annual basis and includes 8% holiday allowance.