Clinical QA Manager/Senior Manager

Location:  Novato, California Category: Quality

Hiring Manager: Rachna Jaiswal ([email protected])

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Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

Clinical QA Manager/Senior Manager - Shanbally, Ringaskiddy, Cork

Hybrid role

Closing Date: 16 December 2024

Clinical QA Manager/Senior Manage is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

 SUMMARY DESCRIPTION
The Clinical QA/QP (Manager/Senior Manager), External Quality is responsible for providing Quality oversight and ensuring GMP compliance of Contract Development Manufacturing Organizations (CDMOs) during clinical cGMP/manufacturing.  
This role seeks to develop a detailed knowledge of the CDMO manufacturing processes and systems and maintains an up-to-date knowledge of Heath authority and Licensing requirements. It enables an effective Quality risk-based oversight of the CDMO including the manufacturing process (and associated facility/utility and equipment), Quality Control (QC) testing, storage, release, and shipping.
The Clinical QA/QP (Manager/Senior Manager), External Quality acts as the Single Point of Contact (SPOC) for Quality in a cross-functional GEO Process Team (Operations, Quality, Manufacturing Science & Technology and Supply Chain) overseeing Contract Development Manufacturing Organisations. This includes Quality & Technical Agreements (QTAs), oversight of CDMO Manufacturing, deviations, change controls, complaints, Quality Risk Assessments (QRAs), Site/Virtual QRMs, Support for Audits/Inspections and lot review/release. The role works to build effective partnerships with internal and external stakeholders (e.g., QA Operations, QP, Compliance, Quality Control, Regulatory) to assess the performance of the CDMOs, improve and reduce risk at CDMO operations and ensure that all Quality and Compliance requirements are defined and met.  
The position requires thorough knowledge and experience with EU & FDA GMP regulations for clinical trials as well as developed managerial, organizational, and project management skills.
The Clinical QA/QP (Manager/Senior Manager), External Quality will build strong cross functional partnerships with Global External Operations and with Contract Manufacturing Organization (CDMO) sites, to ensure effective communications and oversight of CDMO operations.  
 
BioMarin has a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills. 
 
RESPONSIBILITIES 
The responsibilities in the role include the following:
  • Lead the Quality oversight strategy for the CDMOs by assessing CDMOs performance and adjusting Quality oversight as appropriate.
  • Partner cross-functionally with relevant stakeholders to ensure Quality, Manufacturing and Supply needs are met by the CDMOs.
  • Develop plans to reduce risk level and improve performance in partnership with CDMOs.
  • Ensure Quality Review Meetings (QRM) with CDMO are conducted as required.
  • Review and Release lots as required.
  • Ensure QTAs are maintained and administered as required.
  • Manage and oversee deviations, change controls & complaints.
  • Work in partnership with BioMarin Global Compliance & Ethics (GCE) to schedule compliance audits and resolve any compliance gaps identified including from Health Authorities.
  • Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and cGMP regulations.
  • Lead and/or participate in Quality Risk Assessments for significant events such as changes, deviations, product complaints and compliance gaps
  • QP Certification Preferred
Education and Experience 
  • Bachelors or Masters (Science)
  • More than 10 years of professional quality experience in the pharmaceutical and/or medical technology industry in various roles
  • Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
  • Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
  • Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
  • QP Certification desirable
This position will interact with other departments throughout the organization.  This position will partner with and influence within Quality (Quality Process Managers), Operations, Regulatory Affairs, Compliance, Technical Development, Finance, MSAT, and other departments as required.
*Travel requirement: Up to 20%
Note:  This description is not intended to be all-inclusive, or a limitation of the duties of the position.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned.


Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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