Quality Manager – GEO Process Team, QA Operations, External Quality
Description
Who We Are
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.
Quality Manager – GEO Process Team, QA Operations, External Quality
Hybrid Role - onsite 2-3 days per week in Cork or Dublin
Closing Date: Friday 12th April 2024
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
SUMMARY DESCRIPTION
The Quality Manager – GEO Process Team in External Quality / GEO Site is responsible for providing Quality oversight and ensuring GMP compliance of Contract Manufacturing Organizations (CMOs) during commercial cGMP manufacturing.
This role seeks to develop a detailed knowledge of the CMO 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 CMO including the manufacturing process (and associated facility/utility and equipment), Quality Control (QC) testing, storage, release, and shipping.
The Quality Manager – GEO Process Team 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 Manufacturing Organisations. This includes Quality & Technical Agreements (QTAs), oversight of CMO Manufacturing, deviations, change controls, complaints, Quality Risk Assessments (QRAs), and lot release. The role works to build effective partnerships with Quality counterparts at both the CMO and with internal departments (e.g., QA Operations, QP, Compliance, Quality Control, Regulatory) to assess the health of the CMO, improve and reduce risk at CMO 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 as well as developed managerial, organizational, and project management skills. The Quality Manager – GEO Process Team will build strong cross functional partnerships with Global External Operations and with Contract Manufacturing Organization (CMO) sites, to ensure effective communications and oversight of CMO 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 CMO by assessing CMO health and adjusting Quality oversight as appropriate.
- Partner cross-functionally to ensure Quality, Manufacturing and Supply needs are met by the CMO.
- Develop plans to reduce risk level and improve performance in partnership with CMOs.
- Ensure Quality Review Meetings (QRM) with CMO are conducted as required
- Ensure QTAs are maintained and administered as required.
- 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 GMP regulations.
- In collaboration with the CMO; review, assess, approve CMO changes, deviations and complaints.
- Lead and/or participate in Quality Risk Assessments for significant events such as changes, deviations, product complaints and compliance gaps
This position will interact with other departments throughout the organization. This position will partner with and influence within Quality (QP’s, Quality Process Managers), Operations, Regulatory Affairs, Compliance, Technical Development, Finance, MSAT, and other departments as required.
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.
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.