Sr. Director, Development Sciences Quality - 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.
The Senior Director position is a leadership role with substantial strategic input and organizational change opportunity in DSQ Quality Operations. At this stage, deep expertise in leadership and people management is achieved, and the Senior Director is active in motivating, inspiring, training and enabling others in career development. The Senior Director shapes and defines the organizational strategy, and in so doing, demonstrates a mastery of navigating myriad complex and ambiguous DSQ and organization-wide scenarios.
- Oversee the management of quality issues or events that arise within DevSci functions, studies or project teams; Act as an escalation point as needed
- Oversee the documentation, investigation, and resolution of all DevSci SOP by supporting functions, study and project teams
- Oversee the review, approval, and effectiveness checking of all closed CAPAs as a result of DevSci SOP and protocol deviations
Clinical Trial Risk Management:
- Oversee clinical trial and investigation medicinal product (IMP) risk management activities verifying interdisciplinary teams of subject matter experts (SME’s) are established, coordinated/managed and have available appropriate channels of communication/reporting
- Oversee a systematic process for the assessment, control, communication and continual review of risks to quality throughout the clinical trial life-cycle
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
- Oversee risk based quality assessments of processes and procedures, as assigned, and communicate findings to respective DevSci functional stakeholders and DevSci Management
Quality Process Improvement
- Oversee the development and continuous improvement of DevSci Quality processes, systems, and written procedures.
- Lead DevSci Quality Improvements utilizing DevSci Quality’s improvement process (Quality Improvement Plan [QIP] process).
- Lead 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 and assess opportunities to develop and improve key elements of the DevSci Quality Management System.
- Collaborate with Compliance on the identification and understanding of requirements on any new regulatory requirements
- Oversee 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.
Inspection / Audit Readiness and Response Management:
- Actively participate in company-wide Inspection Readiness plans and lead DevSci Quality’s Inspection Readiness plans to strengthen DevSci performance during internal Audits and Regulatory and Health Agency Inspections.
- Partner with Compliance on Audit or Inspection follow-up and/or preparation activities to continually improve response readiness and the overall response process
Inspection / Audit response and CAPA follow-up:
- Collaborate with Compliance to review the impact of all DevSci related Audit and Inspection findings
- Verify adequacy of all DevSci Inspection and Audit responses
- Verify that quality checks on all Corrective and Preventive Action Plans (CAPAs) from Audits and Inspections achieve timely closure.
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.
- Take a leadership role in the identification, assessment and implementation of complex and high profile cross-functional quality improvement initiatives
- 14+ years of relevant pharmaceutical industry experience
- 6+ 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
- BA/BS in life sciences or technical area; advanced degree preferred.
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.