Director, QA CMO Biologics Drug Product and Packaging
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.
This position reports to the Director of Quality Assurance Contraction Manufacturing Organizations (CMO) and will maintain responsibility, leadership, oversight and management of all QA-related activities at BioMarin’s CMOs that manufacture biologics (Drug Product, Labeling, Packaging). Key responsibilities include:
- Development of staff
- Batch Record Review and approval
- Deviation, CAPA, change control and master label approvals
- Primary QA representative and liaison to CMOs and BioMarin partners
- Oversight and management of all QA related activities at CMOs
- Partnering with BioMarin CMO counterparts to achieve shared goals and objectives
- Up to 25% travel may be required.
- Plan, organize, and direct the QA CMO biologics group
- Take the initiative to create and implement a plan to enhance, optimize and improve QA CMO systems
- Establish operational objectives and metrics
- Establish effective communication and collaborative relationships with other functional groups and key stakeholders
- Represent QA CMO and participate in cross-functional meetings
- Develop, define, and enforce departmental policies and practices for functional groups
- Forecast and help manage cost center budget and staffing needs (internal and external)
- Hire, train, develop, evaluate, and support supervisors and employees in group
- Establish performance goals and strategic/operational objectives for direct reports based on company and departmental goals
- Evaluate and manage employee performance, productivity and concerns
- Train employees in inspection requirements and promote technical development
- Lead QA oversight activities at relevant CMOs
- Make lot disposition decisions for Drug Product and Label/Pack lots, including
- Timely review of batch records associated with Bulk DP and packaged and labeled DP
- Timely release and issuance of CofC of DS and DP lots
- Approve deviations, investigations, CAPAs, change requests, etc. from CMOs
- Work with a cross-functional team to ensure adequate supply
- Prepare sections of annual product reviews
- Lead efforts to generate and/or revise Quality & Technical Agreements with CMOs for biologics
- Perform lot assessments as needed
- Manage and maintain good relationships with partners
- Support regulatory agency, partner and QP inspections
- Support regulatory filings
- Support product launch activities
- Support process validation activities
- Other duties as assigned
BS or BA in a technical discipline; advanced degree preferred.
- 12+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency of quality systems, lot release and quality activities.
- 7+ years experience in a management or supervisory position, with direct experience overseeing quality assurance activities.
- Excellent leadership, technical, management, problem solving and project management skills
- Organizational and management skills to handle multiple functional groups, with ability to effectively delegate work
- Ability to speak, present data, and defend approaches in front of audiences and inspectors
- Experience in participating in regulatory inspections, presenting/defending departmental functions in audits or regulatory inspections (specific experience in defending quality systems preferred, but not required)
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for departmental functions (understanding of regulatory guidelines for other countries a plus)
- Good report writing skills for regulatory review
This position will require interaction with multiple levels (from entry level employees up to Senior/Executive Management) in Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Contract Manufacturing, Regulatory Affairs, Clinical Operations, Pharmacovigilance, Medical Affairs, Legal, Accounting, Finance, and Human Resources.
- This position will oversee a group of ~ 15 full time employees.
- This position will lead and oversee cross-functional teams associated with QA-led initiatives and efforts.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.