Sr. Director, Quality Control & Analytical Development

Sr. Director, Quality Control and Analytical DevelopmentThe Sr. Director, Quality Control and Analytical Development provides strategic, technical, and operational leadership to the site Quality Control and Analytical Development Laboratories. This role proactively leads implementation of GMP industry standard methodologies across the Quality Control and Analytical Development Laboratories. The Sr. Director, Quality Control and Analytical Development play a major role in the site operations while remaining adaptable to the changing needs for new clients and programs and is accountable for the sustained and ever-improving quality mindset as well as the consistent adherence to current good manufacturing practices (cGMP) throughout the site.What You'll Do:Develops and implements the strategy and roadmap for Quality Control and Analytical Development with the overall Global Quality StrategyBuilds, develops and leads the QC and Analytical Development team with intention, providing clear priorities, feedback and career development opportunities in alignment with the department's objectivesProvides strategic decision-making; prioritizes deliverables to meet site and compliance objectivesOverseeing all Analytical Development operations including leading internal teams in developing, qualifying, and validating analytical methods.Overseeing all QC operations including In Process Testing, Bulk Release and Stability Testing, Microbiological Testing, the Environmental and Utility Monitoring programOverseeing contracted testing labs (CROs) for method transfer and compliance.Supports and participates in client visits, audits, and regulatory agency inspectionsEnsures budgets, timelines, schedules and performance requirements are established and metAssures all areas of responsibility conform to cGMP and other appropriate regulatoryInteracts and meets regularly with cross-functional leaders on matters concerning their functional areas, groups or clientsAssures that all areas of responsibility are cGMP compliant and audit-readyOverseeing the development and implementation of standards, methods and procedures for testing and evaluating the quality and safety of productsManages technology transfers and method improvements needed to ensure reliable, robust, fit for purpose, and cGMP compliant methods available for the laboratoriesAdministers company policies such as time off, shift work, and inclement weather that directly impact employeesCompletes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)Coaches and guides direct reports to foster professional developmentParticipates in the recruitment process and retention strategies to attract and retain talent, as neededAddresses performance gaps, employee questions and concerns, and partners with HR as needed for resolutionPerforms all other duties, as assignedMinimum Requirements:Bachelor's Degree in Chemistry, Biochemistry, Microbiology or related field with 15+ years of experience ORMaster of Science (M.Sc.) in a related discipline with 13+ years of experience ORPh.D. in Science with 11+ years of experience12+ years of people management, leadership, and team management experienceTechnical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an understanding of control strategyExperience leading client site visits, audits, and regulatory inspectionsExperience managing in a matrix organization and collaborating at a global levelExperience working in a regulated GMP environmentPreferred Qualifications:12+ years of experience working in a regulated GMP environmentStrong orientation for quality, compliance, business ethics and customer service.Strong leadership, collaboration, team building, program management and organizational skillsProven ability to develop, communicate, and execute plans and strategies with a wide range of stakeholdersHigh level of integrity and a drive for continuous improvementStrong collaboration and team building skillsExcellent judgment and creative problem-solving skills, including negotiation and conflict resolutionExcellent interpersonal, organizational, and written and oral communication skillsMastery knowledge of document management and lifecycle, and quality systems and their interconnectionsMastery of GMP, regulations, and inspection/audit readinessAbility to coach, lead, and develop individual contributorsMust be flexible to support 24/7 manufacturing facilityWorking & Physical Conditions:Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.Ability to discern audible cues.Ability to sit for prolonged periods of time up to 60 minutes.Ability to conduct activities using repetitive motions that include wrists, hands or fingers.Ability to conduct work that includes moving objects up to 10 pounds.