Sr. Director, Quality Control & Analytical Development

Position Overview

The 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.

Job Description

What You'll Do:

· Develops and implements the strategy and roadmap for Quality Control and Analytical Development with the overall Global Quality Strategy
· Builds, 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 objectives
· Provides strategic decision-making; prioritizes deliverables to meet site and compliance objectives
· Overseeing 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 program
· Overseeing contracted testing labs (CROs) for method transfer and compliance.
· Supports and participates in client visits, audits, and regulatory agency inspections
· Ensures budgets, timelines, schedules and performance requirements are established and met
· Assures all areas of responsibility conform to cGMP and other appropriate regulatory
· Interacts and meets regularly with cross-functional leaders on matters concerning their functional areas, groups or clients
· Assures that all areas of responsibility are cGMP compliant and audit-ready
· Overseeing the development and implementation of standards, methods and procedures for testing and evaluating the quality and safety of products
· Manages technology transfers and method improvements needed to ensure reliable, robust, fit for purpose, and cGMP compliant methods available for the laboratories
· Administers company policies such as time off, shift work, and inclement weather that directly impact employees
· Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.)
· Coaches and guides direct reports to foster professional development
· Participates in the recruitment process and retention strategies to attract and retain talent, as needed
· Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution
· Performs all other duties, as assigned

Minimum Requirements:

· Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related field with 15 years of experience OR

· Master of Science (M.Sc.) in a related discipline with 13 years of experience OR

· Ph.D. in Science with 11 years of experience

· 12 years of people management, leadership, and team management experience

· Technical and regulatory understanding and experience of biologics, gene, and/or cell therapy QC with an      understanding of control strategy

· Experience leading client site visits, audits, and regulatory inspections

· Experience managing in a matrix organization and collaborating at a global level

· Experience working in a regulated GMP environment

Preferred Qualifications:

· 12 years of experience working in a regulated GMP environment

Knowledge, Skills, or Abilities:

· Strong orientation for quality, compliance, business ethics and customer service.

· Strong leadership, collaboration, team building, program management and organizational skills

· Proven ability to develop, communicate, and execute plans and strategies with a wide range of stakeholders

· High level of integrity and a drive for continuous improvement

· Strong collaboration and team building skills

· Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution

· Excellent interpersonal, organizational, and written and oral communication skills

· Mastery knowledge of document management and lifecycle, and quality systems and their interconnections

· Mastery of GMP, regulations, and inspection/audit readiness

· Ability to coach, lead, and develop individual contributors

· Must be flexible to support 24/7 manufacturing facility

Working & 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.