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 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.
The Sr. Director demonstrates mastery skills in all DSQ core and technical competency areas.
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.
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
The Sr. Director must seek to effectively lead the organization, build a strong team by coaching and mentoring others, make impeccable decisions, and ensure the success of the business. To achieve these ends, mastery of all core competencies is essential. The Sr. Director should:
Have a clear vision for the future of the business based on a big picture understanding of company strategy, and be able to effectively articulate this vision to others
Prioritize career development by inspiring and motivating others while proactively acknowledging the progress, growth and success of individuals and teams
Similarly, mastery of all technical competencies for the DSQ group will position the Sr. Director for success in this highly strategic position.
12+ years of relevant pharmaceutical industry experience
4+ years of people management experience
Accomplishes desired results of a corporate function
Seasoned leader capable of managing large and diverse teams
Full strategic responsibility for an area of significant corporate impact
Serves as a principal spokesperson for organizational unit regularly interacting with senior leaders
BA/BS in life sciences or technical area; advanced degree preferred. Experience in lieu of education may be considered.
Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus