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Johnson & Johnson Innovative Medicine is recruiting for a Senior Compliance Specialist, to be located at the Cork Small Molecule site in Ireland.

The Cork Small Molecule site is a drug substance manufacturing site responsible for the manufacturing, testing and supply of several non-sterile/sterile API’s.

This position will execute the internal audit program, prepare and lead external audits, provide compliance subject matter expertise and deploy compliance initiative at the site.

Are you interested in actively crafting the compliance of the site? Apply now for this exciting opportunity!

Your key responsibilities

• Implement and execute internal audits program at the site (schedule, agenda, prepare and conduct audit, report writing, review of internal audits investigation responses).

• Responsible for training and qualifying auditors.

• Facilitate and support external GMP audits and inspections (Health Authority, Customer), including the coordination of inspection back room.

• Inspection Readiness: lead compliance walk-throughs, audit preparation, coaching the SMEs.

• Provide compliance subject matter expertise and compliance training to the manufacturing site, including identifying changes in regulations that impact procedures and current practices.

• Implement compliance initiatives and projects at the site, in alignment with Global Innovative Medicine Regulatory Compliance (IMRC).

• Partner with site to proactively identify risks and drive compliance improvement across the site.

• Represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, …

• Ensure timely and accurate reporting of compliance metrics.

Qualifications

Qualifications

Education:

• A minimum of a Bachelor's Degree or equivalent experience in Science or related field.

Experience and Skills

Required:

• At least 5 years related experience in a GMP-regulated industry and at least 1 year of regulatory compliance experience.

• Solid understanding of global GMP regulations

• Experience preparing, handling and/or supporting inspections.

• Strong analytical skills and ability to clearly articulate issues.

• Excellent interpersonal skills, able to quickly build credibility with the site and within the Quality and Compliance community.

• A creative, flexible approach to new challenges!

Preferred:

• Expertise on Health Authority and Pharma Quality System regulations, with the ability to relate these to business/quality issues.

• Experience performing internal audits is strongly preferred (lead auditor certification).

Other:

• Domestic / International travel is possible (5%-10%)

This is a Flex position that requires 3 days on site, and 2 days remote, with exception of audit and inspection period, where on site presence is needed. Other arrangements may be considered on a case-by-case basis and if approved by the Company.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.]