Description
Change lives for the better.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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 OPPORTUNITY
This position will be accountable for the site internal quality program and external GMP audit and inspection management programs. You will lead and/or coordinate teams of site-based compliance personnel delivering both programs. You will deploy compliance initiatives for the site in alignment with Pharmaceutical Regulatory Compliance.
Next to that, this position will execute the internal audit program at the pharmaceutical manufacturing sites. You will prepare and manage external GMP audits and inspections (e.g. Health Authority, Customer, ERC, etc.). You will also provide compliance subject matter expertise to the manufacturing sites and site-based projects. Finally, you will deploy compliance initiatives for the site in alignment with Pharmaceutical Regulatory Compliance.
Further responsibilities:
- Responsible for site internal audit program including:
- Establish and create schedule.
- Auditor training (qualify and evaluate).
- 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.
- Maintain site inspection readiness program for external GMP audits and inspections (Health Authority, Customer). Facilitate inspection management (front room, back room, coaching).
- Lead the site response efforts including assignment of appropriate CAPAs.
- 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 Mgt) and partner with sites on J&J standard implementation.
- Ensure appropriate and timely escalation of risks to the appropriate leadership and regulatory compliance teams. Facilitate remediation of compliance risks.
- 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.
- Establish a high performance and continuous improvement culture driven by key performance metrics, benchmarking and sharing of best practices.
- As applicable, report progress of site compliance remediation plans (e.g. MCAP, SDCAP, etc.).
- 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/backroom support). Review and provide input to site response, and associated CAPAs, to ERC audits.
- Coordinate, maintain, report and drive site compliance metrics.
- Establish department policy, standard operations procedures and working practices.
- Coordinate compliance training for the site.
- Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards.
- As needed, provide training for Quality concepts and/or systems.
- As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.
- Conduct Mock Recalls.
Qualifications
IT’S ALL ABOUT YOU
To be successful, you demonstrate the ability to communicate effectively at all levels within a virtual matrix environment. Further requirements include:
- Minimum bachelor’s degree in science or related field.
- At least 7 years related experience in a GMP-regulated industry and at least 2 years of regulatory compliance experience.
- Extensive knowledge of global GMP regulations is required.
- Experience performing internal or external audits is required.
- Strong analytical skills and ability to clearly articulate issues.
- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance community and management.
- Delivers on commitment timelines and has high sense of urgency.
- Experience preparing for inspections, managing inspections and/or supporting inspections.
- Domestic travel is possible. Potential for limited international travel.
- QA/RA certification is preferred.
- Preferred experience in change management and project management.
- Preferred people management experience.
Are you ready to make an impact?
If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.
We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.
Closing date: Wednesday 29th of January 2025.
Being part of Johnson & Johnson can change everything, including YOU
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
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.