Manager, Development Sciences Quality Operations - United States
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 Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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.
Development Sciences Quality (DSQ) Functional Overview:
The Development Sciences Quality (DSQ) group is focused on partnering with Development Sciences 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 is a critical execution position in the DSQ group. The Manager holds responsibility within the DSQ organization in the areas of: Quality Operations. The Manager demonstrates a significant amount of subject matter expertise and independence as s/he focuses on more complex studies and quality risks and issues. Responsibilities may include reporting and communicating SOP deviation and CAPA performance metrics, verifying adequacy of DevSci Inspection and Audit responses, or involvement in the quality review of the TMF for assigned studies. At this stage, the Manager may be offered opportunities to take on leadership roles in key internal initiatives, take on a study team representation role.
- 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
- Partner with cross-functional stakeholders to address issues or quality events related to quality systems or processes
- Collaborate with teams and functional areas and oversee the documentation, investigation, and resolution of all DevSci SOP deviations
- Report and communicate SOP deviation and CAPA performance metrics to relevant audiences
- Verify the appropriate closure of all SOP deviations and related CAPAs;
- Perform effectiveness checks on all applicable closed CAPAs ; provide Study and Project teams with protocol deviation trend analysis and verify performance trends are addressed and adjudicate
- Participate in assigned Study Team meetings as designated DSQ Lead
- Participate in quality review of all applicable regulatory documents including but not limited to; protocols and amendments, IB’s, Study Specific Plans, ICFs, Clinical Study Reports
I. Quality Guidance on Essential Study Documents and Regulatory Submission Documents
- For moderately complex studies, 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
- Respective DevSci functional stakeholders and DevSci Management
- Perform risk based quality assessments of processes and procedures, as assigned, and communicate findings
II. Quality Process Improvement
- Support or participate in the execution of DevSci Quality Improvements utilizing DevSci Quality’s improvement process (Quality Improvement Plan [QIP] process).
- Collaborate on process improvement initiatives 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, assess and communicate 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.
IV. Inspection / Audit response and CAPA follow-up
- 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 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.
V. Inspection Activity Awareness
- Liaise with the BioMarin Compliance function to identify Audit and Inspection activity or plans that will impact DevSci; facilitate coordination across DevSci studies, sites, and vendors.
VI. TMF-Related Collaboration & Support
- Support all TMF collaboration activities for studies and maintain awareness of study events and the associated documentation requirements
VII. Comprehensive Review
- Participate in the conduct of quality review of the TMF for each assigned study on an annual basis per the time points captured in the study-specific TMF Plan.
VIII. Records Management
- Support the implementation of standards and processes for DevSci records management to verify compliance with relevant regulations
- Collaborate and support execution of processes associated with the storing, archiving, indexing, scanning and classifying records
Education & 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.