Director, Drug Product Market Release
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 leader of the external quality organization and will maintain responsibility, leadership, oversight, and management of quality-related activities for drug product releases in US, EU, and rest of world markets. Responsibilities consist of establishing the compliance profile and quality mindset for the team including planning, implementation, and management of applicable Quality Systems and oversight of suppliers i.e. CMOs, Distributors, Testing Labs, etc. This position will work closely with and serve as a business partner to Technical Operations, Business Development, Project Management, Commercial Operations, and Clinical Operations. This position will be located in Novato, CA and requires international travel.
Key responsibilities include:
- Development of staff
- Supports market planning processes
- Oversight of Commercial and Clinical Batch Releases
- Supports Product Complaint investigations and summaries
- QA representative and liaison to CMOs and business partners
- QA representative for Health Authority interactions, application reviews, and notifications
- Oversight and management of QA related activities for global product release, including quality agreements
- Partners with BioMarin counterparts to achieve shared goals and objectives
- Oversight quality requirements for global product distribution
- Support investigation of distribution deviations that impact relationship with health authorities
- Support quality readiness for inspection activities to hold authorization for commercialization
- Support In country test abroad
- Support quality initiatives for global business improvement
- Up to 25% travel may be required
- Plan, organize, and direct the QA Market Release group
- Take the initiative to create and implement a plan to enhance, optimize and improve systems required for efficient product release
- Establish operational objectives and metrics
- Establish effective communication and collaborative relationships with other functional groups and key stakeholders
- Represent QA, participate in, and lead 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 relevant to product release activities
- Ensure timely review of batch information to facilitate secondary release and oversight of outsourced functions
- As necessary, approve deviations, investigations, CAPAs, change requests, etc.
- 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 or intercompany
- Perform lot assessments as needed
- Manage and maintain good relationships with business partners
- Support regulatory agency, partner and QP inspections
- Support regulatory filings
- Support product launch activities
- Support process validation activities (product, process, equipment, transport)
- Other duties as assigned
BS or BA in a technical discipline; advanced degree preferred.
- 12+ years of experience in a GMP regulated environment, with exhibited knowledge and proficiency of quality systems, lot release and quality activities.
- 7+ years of 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)
- Knowledge of the Qualified Person (QP) release processes and regulations with respect to the EU, and equivalent regulations globally
- Good report writing skills for regulatory review
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.