Regulatory Compliance Lead

2 days ago


Fremont, California, United States Novo Nordisk Pharma Full time

About Novo Nordisk
Novo Nordisk is a leading global healthcare company dedicated to discovering and developing innovative therapies that improve the lives of individuals with chronic conditions, particularly diabetes.

Position Overview
The Compliance Manager plays a crucial role in ensuring that all manufacturing operations adhere to applicable 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 managing complex investigations related to 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 aimed at educating manufacturing staff 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 enhance processes.
- Generate change controls and perform risk and impact assessments.
- Oversee and document manufacturing quality events, including deviations and change controls.
- Author and manage deviation reports, leading investigations to resolution.
- Employ problem-solving techniques, such as fishbone diagrams and 5 Whys, to determine root causes of deviations and initiate corrective actions.
- Facilitate meetings with internal review teams and subject matter experts to align on investigational strategies.
- Collaborate closely with the manufacturing team to analyze quality event data and provide leadership updates on quality status.

Documentation and Audits
- Author, revise, and review controlled documents (e.g., batch records, SOPs) to ensure compliance with cGMP standards.
- Lead audit and inspection readiness activities, representing manufacturing during internal and external audits, and addressing any findings.
- Conduct periodic reviews of departmental documentation to ensure adherence to established quality standards and regulatory requirements.

Qualifications
- Bachelor's degree preferred, ideally in a life sciences discipline, 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.
- At least three years of demonstrated leadership experience in compliance and continuous improvement within the biotechnology or pharmaceutical sectors.
- Proficient in writing compliance documentation, including investigations, deviations, and technical reports.
- Strong communication skills, capable of engaging 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 workplace that values diverse perspectives and backgrounds. We believe that a diverse workforce is essential to our mission of improving global health.



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