Compliance Manager

4 weeks ago

Fremont, California, United States Novo Nordisk Pharma Full time
About the Role

We are seeking a highly skilled Compliance Manager to join our team at Novo Nordisk Pharma. As a Compliance Manager, you will be responsible for ensuring that our manufacturing processes are executed in compliance with regulations and standards.

Key Responsibilities
  • Provide guidance and support to the manufacturing team to ensure ongoing compliance with regulatory and internal requirements.
  • Develop and deliver training programs to educate manufacturing personnel on compliance requirements.
  • Conduct risk assessments to identify compliance gaps and develop mitigation strategies.
  • Drive systematic problem solving (SPS) for investigations and use metrics and trends for process improvements.
  • Generate change controls, perform risk, and impact assessments.
  • Coordinate and document manufacturing quality events including but not limited to deviations and Change Controls.
  • Lead investigations for manufacturing quality events and bring them to a resolution serving as primary author of deviation reports.
  • Utilize problem solving methodologies such as go, look, see by going to the production areas for data gathering, observing of processes for investigations, and conducting associate interviews.
  • Generate fishbone diagrams, and 5 Whys to establish root cause of deviations.
  • Initiate appropriate corrective actions to prevent recurrence.
  • Lead meetings, aligning internal review teams and area subject matter experts on an agreed upon investigational path forward.
  • Work closely with manufacturing team to review and evaluate quality event information and trends.
  • Provide updates to leadership on status of quality events.
  • Author, revise and review controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures.
  • Lead activities for audits and inspection readiness.
  • Represent manufacturing in internal and external audits, and address audit findings.
  • Collaborate with stakeholders to address compliance gaps identified in audits and inspections.
  • Provide periodic review of department documentation and records such as logbooks, SOPs, etc. to assess for compliance with internal and regulatory requirements, established quality standards, policies, and procedures.
  • Stay updated on relevant regulations and guidelines in the cell therapy manufacturing industry, review and interpret regulatory requirements to ensure compliance in manufacturing processes.
Requirements
  • Bachelor's degree preferred (degree in the life sciences field preferred) with 7 years relevant experience.
  • Minimum of Associate degree required; Associates degree requires 9+ years of experience within cell culture in a controlled environment.
  • Advanced degree may be substituted for experience as appropriate.
  • Minimum of three years of proven leadership experience in driving compliance and continuous improvement within Biotechnology or Pharmaceutical organizations.
  • This encompasses leading peers and collaborating in cross-functional teams.
  • Ability to communicate to all levels of the organization, cross-functional teams, and various knowledge levels.
  • Experience writing investigation, deviations, change control documentation, technical reports, batch records, standard operating procedures, and other cGMP documentation is required.
  • Proven capacity to work autonomously while remaining open to input, employing diplomacy and persuasion to address challenges and achieve mutually beneficial resolutions.
  • Demonstrated ability to identify, challenge, and implement potential improvements to work procedures.
  • Highly motivated and comfortable working in a results-oriented dynamic research and development environment.
  • Ability to lead teams consisting of members with different degrees of knowledge or ability.
  • Excellent leadership, communication (oral and written), presentation, and interpersonal skills.
  • Knowledge of manufacturing processes including experience in cell culture, and aseptic handling is preferred.

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