[Innovative Medicine] Senior Compliance Specialist, Quality Compliance Group, Quality Operations Dep

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

The Innovative Medicines Regulatory Compliance organization is recruiting for a Senior Compliance Specialist.

This position will be based in the Fuji site, Japan.

DESCRIPTION

The Senior Compliance Specialist reports directly to the Director, J&J Regulatory Compliance (Japan).

This position will execute the internal audit program at the Fuji site, prepare and manage external GMP audits and inspections (e.g.

Health Authority, Customer, ERC, etc.), provide compliance subject matter expertise to the manufacturing site and site-based projects, deploy compliance initiatives for the site in alignment with Innovative Medicines Regulatory Compliance.

RESPONSIBILITIES


* 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 into COMET
+ Enter GEMBA findings into the appropriate database


* 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.


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

Implement J&J Compliance Standards (e.g.

Audit/Inspection Management) and
partner with sites on J&J standard implementation.


* 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 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.


* As applicable, monitor progress of site compliance remediation plans (e.g.

MCAP, SDCAP, etc.)


* Collaborate with other groups in IM...