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Regulatory Compliance Lead
2 months ago
About Novo Nordisk
Novo Nordisk is a leading global healthcare company dedicated to discovering and developing innovative therapies aimed at improving the lives of individuals with diabetes and other serious chronic conditions.
Position Overview
The Compliance Manager plays a critical role in ensuring that all manufacturing processes adhere to established regulations and standards, including ATMP, 21CFR, 210, 211, 600, 610, ICH, cGMP, ISO, and corporate/local SOPs and MBRs. This position is pivotal in driving quality enhancements and leading intricate investigations into manufacturing quality incidents.
Key Responsibilities
- Provide expert guidance and support to the manufacturing team to maintain compliance with regulatory and internal standards.
- Develop and implement training programs to educate personnel on compliance protocols.
- Conduct thorough risk assessments to identify compliance deficiencies and formulate mitigation strategies.
- Lead systematic problem-solving initiatives for investigations, utilizing metrics and trends to drive process improvements.
- Generate and manage change controls, performing risk and impact assessments.
- Document and coordinate manufacturing quality events, including deviations and change controls.
- Oversee investigations into manufacturing quality incidents, authoring deviation reports and ensuring timely resolutions.
Collaboration and Communication
- Collaborate closely with internal stakeholders to review and assess quality event information and trends.
- Provide regular updates to leadership regarding the status of quality events.
- Author, revise, and review controlled documents (batch records, logbooks, SOPs, etc.) to ensure compliance with cGMP standards.
Audit and Inspection Readiness
- Lead activities to prepare for audits and inspections, representing manufacturing during internal and external audits and addressing any findings.
- Work with stakeholders to rectify compliance gaps identified during audits.
Qualifications
- A Bachelor’s degree is preferred, ideally in a life sciences field, with a minimum of 7 years of relevant experience.
- An Associate degree is acceptable with 9+ years of experience in a controlled cell culture environment.
- Proven leadership experience in compliance and continuous improvement within the biotechnology or pharmaceutical sectors is essential.
- Strong communication skills are required to effectively engage with all organizational levels and cross-functional teams.
Work Environment
- This role may require up to 10% overnight travel.
Commitment to Diversity
Novo Nordisk is committed to fostering an inclusive culture that values diverse perspectives and backgrounds, ensuring equal opportunity for all applicants.
