Job Title: Sr. Manager, Novato Manufacturing Investigations
The Sr. Manager of Manufacturing Investigations is responsible for managing the performance of the critical compliance functions of investigations. This role manages a group that assures deviation record management is in a state of compliance with all BioMarin standards and current industry and regulatory standards. The role also establishes the systems by which these compliance activities are executed in an organized and efficient manner.
The role includes involvement in Deviations, CAPAs, Effectiveness Checks and Change Control. Investigations within the scope of this role are:
- Manufacturing Deviation Events (Moderate and Major)
- Supply Chain Operations Deviation Events (Moderate and Major)
- California Facilities and Engineering Deviation Events (Moderate and Major)
The scope covers commercial products across various modalities.
This position reports to the Head of Business Operations and is a member of the Business Operations Leadership Team. The successful candidate ensures functional objectives are aligned with company goals and regulatory expectations. The role requires strong structured problem-solving skills, project management skills, and the ability to collaborate with a broad variety of cross-functional departments.
- Provide directives and manage a team of direct reports to assure that Manufacturing investigations are in a state of compliance with all BioMarin standards and current industry and regulatory standards.
- Ensure appropriate resources are allocated and implemented for Manufacturing investigation compliance.
- Develop and improve policies, procedures and business practices to maintain and/or enhance compliance status.
- Implement the concepts of Operational Excellence and Structured Problem solving to appropriate systems and processes to enable the efficient and effective investigations.
- The position effects continuous-improvement initiatives by:
- Leading a team of professionals with specialized job functions addressing Manufacturing investigations.
- Mapping and identifying metrics to monitor current business processes and identifying and implementing process improvements.
- Building cross-functional workgroups and teams and facilitating identification of goals and delineation of responsibility.
- Communicating systems improvements effectively to ensure efficient adoption.
- Documenting systems improvements in SOPs and policy documents.
- Represent the company at regulatory inspections and audits, and defend Manufacturing processes, practices and documentation systems.
- Represent Manufacturing in cross-functional meetings and project teams.
- Establishes efficient processes and systems to track and report status of initiatives including resources, projects, savings, etc.
- Develops team strategy and budget. Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management.
- Other duties as assigned.
- PhD with at least 4 years of experience in a relevant functional area
- M.S. with at least 6 years of experience in a relevant functional area
- B.S. with at least 8-10 years of experience in a relevant functional area
The position requires:
- Demonstrate expertise with Quality Management Systems
- Ability to work independently, managing projects and meeting established timelines.
- Comfortable with managing the activities of other staff members.
- Computer literacy is required. Experience with Quality Management systems) is preferred.
- Prior people management experience preferred.
Management of the Manufacturing Investigations staff.
The position requires:
- Strong leadership skills
- Strong problem solving skills
- Strong facilitation skills
- Well-developed organization skills with exact attention to details.
- Strong deductive reasoning skills
- Excellent written and verbal communication skills.
- Achieving Excellence
- Courage / Challenge
- Develop Self & Others
- GMP Acumen
- Lean Six Sigma Black Belt certification (preferred)
- Critical Thinking & Evaluation
- Organizational Awareness
- Performance Management
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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.