Manager, GCP Development Sciences QualityLocation San Rafael, California Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
OVERVIEW: Development Sciences Quality (DSQ)
The Development Sciences Quality (DSQ) group is focused on partnering with Worldwide R&D functional groups, 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 Manager holds responsibility within the DSQ organization in the area of Quality Operations including, CAPA management, essential document reviews, process improvement projects, metrics analysis and reporting, and inspection readiness/response. The Manager demonstrates a significant amount of subject matter expertise in regulations and GxPs, as well as strong core competencies in organization, planning and communication. The Manager may be offered opportunities to take on lead roles in key internal initiatives, take on a study team representation role, and manage other staff.
- Identify, investigate and manage quality issues or events that arise within DevSci functions, studies or project teams; provide guidance on resolution and facilitate appropriate escalation to DSQ management
- Collaborate with teams and functional areas and oversee the documentation, investigation, and resolution of all DevSci SOP deviations
- Verify the appropriate closure of all protocol deviations and related CAPAs; analyze protocol deviation trends and communicate findings and impacts to affected DevSci functional areas or study teams
- Review and perform effectiveness checks on all closed CAPAs as a result of DevSci SOP and protocol deviations
- Oversee the management of updates to DevSci Trackwise based on user requirements
Quality Guidance on Essential Study Documents and Regulatory Submission Documents
- Conduct risk based reviews and provide guidance on essential regulatory required documents including, but not limited to, clinical protocols, investigator’s brochures, case report forms (CRFs), informed consents, monitoring and data management plans for GCP compliance and inspection readiness
- Perform risk based quality assessments of processes and procedures, as assigned, and communicate findings to respective DevSci functional stakeholders and DevSci Management
Quality Process Improvement
- Lead or participate in the execution of DevSci Quality process improvement projects across the DevSci organization verifying that fit for purpose quality practices are implemented throughout functional areas within DevSci
- Maintain ongoing awareness of industry and organization-wide best practices for quality and share information across DSQ and DevSci as necessary.
- Identify and assess opportunities to develop and improve key elements of the DevSci Quality Management System.
- Support efforts to collaborate with Compliance on understanding of requirements on any new regulatory requirements; for any new regulations, conduct gap analyses of DevSci systems, processes, and supporting documentation, outline impact, define changes required, and support implementation to verify compliance.
- Support the development, implementation and maintenance of a robust metric tracking and trending and related impact analysis process that provides risk based information to the DevSci organization.
- Provide Study and Project teams with protocol deviation and trend analysis and verify performance trends are addressed and adjudicate
Inspection and Audit Response Management
- Collaborate with Compliance to review and understand impact of all DevSci related Audit and Inspection findings
- Support DevSci functional areas in understanding, interpreting and determining impact of Audit and Inspection finding
- Verify adequacy of all DevSci Inspection and Audit responses by:
- Leading coordination efforts among involved functions and providing status and needs communications
- Supporting, facilitating and assessing adequacy of the development of Audit or Inspection response documentation
- Oversee the creation of Quality Reviews/quality checks of essential regulatory required documents in preparation for Audits and Inspections.
- Review, monitor, and perform quality checks on all Corrective and Preventive Action Plans (CAPAs) from Audits and Inspections to achieve timely closure.
EDUCATION AND EXPERIENCE
- BA/BS in life sciences or technical area; experience in lieu of education may be considered
- 6+ years of relevant pharmaceutical industry experience
- 1 or more years of people management experience
- 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, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.