Associate Director, Quality ManagementLocation San Rafael, California Apply
The Development Sciences Quality (DSQ) group is focused on partnering with functional groups in Worldwide Research and Development (WWRD), project teams and study teams to proactively promote, facilitate and verify the implementation of, and adherence to, good quality practices across the drug development lifecycle in order to be inspection ready at all times. DSQ achieves this by implementing, maintaining and continuously improving a quality management system which includes robust quality operations oversight, controlled document management, eTMF and records management, inspection readiness and response support and training development and delivery.
The Associate Director of Quality Management will be accountable for developing, implementing, and overseeing quality systems and processes within DSQ that contribute to the overall health of our quality management and support to WWRD. This may include but is not limited to oversight of a DSQ quality system area (e.g. Controlled Document management, Quality Training program, eTMF Management and Oversight, DSQ support standardization to study teams). This includes support to ensure operational processes and procedures within WWRD meet regulatory requirements (i.e. adherence to GxP principles and requirements) and that quality and compliance risks and potential gaps are identified and mitigated. In addition, this position will be highly involved in continuous improvement to internal quality practices and systems to deliver improved efficiencies in process management, metrics and analytics reporting. The Associate Director will foster a culture of proactive quality management with peers and senior leaders across WWRD. Broad knowledge of quality management practices and quality systems in the drug development space will facilitate navigating the highly dynamic WWRD organization. This position is a customer/stakeholder-facing position and requires advanced ability to influence and provide leadership in situations that are highly cross-functional and matrixed in a nature.
The Associate Director position is a transitional role to becoming a leader in the organization. The Associate Director will take on projects of significant complexity and strategic importance and may act as a Study Team Representative for higher complexity projects. The Associate Director is regarded as a capable manager and may participate in managing of people in the department, supporting DSQ team members and training staff.
Controlled Document Management and Oversight
Quality System Oversight
• Provide oversight and management of the WWRD Controlled Document governance committee.
• Develop and use metrics and analytics that streamline processes for the drafting, review, and approval of GCP/GLP/GVP Standard Operating Procedures (SOPs), Work Instructions (WI), and other controlled documents for DevSci.
• Drive best practices to ensure WWRD procedures are used, accessible, and reflect regulatory requirements
• Identify and lead system enhancements and collaborate with TOPS and other functional areas to streamline best practices.
Quality Training Program Management and Oversight
Quality System Oversight
• Oversee the design, development, and delivery training and education across WWRD functional areas to advance knowledge and application of quality and GxP topics and use of validated quality systems.
• Identify areas of quality training needs to ensure continuous improvement and the incorporation of new industry best practices related to quality management and GxP compliance are incorporated.
• Use innovative ways to ensure training and education has a broad reach in WWRD’s global environment.
• Partner with WWRD functional areas to support training development requests.
eTMF Management System Oversight
Quality System Oversight
• Develop and use analytics to drive eTMF oversight and quality performance of the system.
• Develop and implement innovative and risk-based approaches to promote eTMF completeness and overall health.
• Devise improvements to eTMF management in different trial execution models (i.e. quality by design thinking based on trial design, outsourced or in-licensed trials).
• Develop and implement standards and processes for document management.
Inspection Readiness Support Responsibilities
Inspection / Audit response and CAPA follow-up
• Serve as a liaison to Compliance on audits that impact WWRD Quality Systems and participate in recommending audit responses and developing/implementing CAPAs that impact quality systems under DSQ oversight.
• Collaborate with Compliance to review and understand impact of WWRD- related Audit and Inspection findings.
• Support WWRD functional areas in understanding, interpreting and determining impact of Audit and Inspection finding
• Verify adequacy of all WWRD Inspection and Audit responses by:
o Overseeing coordination efforts among involved functions
o Supporting, facilitating and assessing adequacy of the development of Audit or Inspection response documentation
• Monitor relevant Corrective and Preventive Action Plans (CAPAs) from Audits and Inspections to achieve timely closure.
• Collaborate with AD of Inspection Readiness Management to identify and improve support to WWRD inspection readiness
People Management and Leadership
• Assume personnel management responsibilities, leveraging BioMarin’s DIAL attributes to further development of DSQ staff.
• Able to credibly identify the development needs of an employee and establish a plan of formal or experience-based training that fits the employee.
• Able to develop an employee’s skills and encourage growth within a defined job family.
• Identifies objectives appropriate for learning-by- doing and the order in which tasks should be mastered, building from basic to complex.
• Able to resolve minor conflicts within department and maintain cooperative teamwork.
• May serve as a DSQ representative on Study Execution Teams in WWRD
• May serve as the lead for internal DSQ initiatives
• May serve as the quality subject matter expert representing DSQ on cross-functional or cross-organizational initiatives
Education & Experience
- BA/BS in life sciences or technical area; experience in lieu of education may be considered
- 8+ years of relevant pharmaceutical industry experience
- 1 or more years of people management experience preferred
- Relevant experience in Sponsor Inspections in various capacities (e.g. inspection management, host or interaction with Health Authorities, inspection prep room support)
- Advanced working and applied knowledge of regulations (e.g. FDA, EMA, MHRA)
- Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus
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.