Compliance Manager

3 weeks ago

Fremont, California, United States BioSpace, Inc. Full time
About the Role

We are seeking a highly skilled Compliance Manager to join our Cell Therapy Manufacturing team. 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.
  • 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.
About Us

BioSpace, Inc. is a global health care company committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. We are conducting research on stem cell therapy, which raises hopes for improved treatment of Type 1 Diabetes and other chronic diseases.

We are an equal opportunity employer and welcome applications from diverse candidates. We offer a competitive salary and benefits package, including medical, dental, and vision coverage, life insurance, disability insurance, 401(k) savings plan, flexible spending accounts, employee assistance program, tuition reimbursement program, and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance, and auto/home insurance.

We are committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, we're life changing.

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