Sr. Director, Quality

About the role

Senior Director of Quality, Quality Site Head at a contract manufacturer of microbial fermentation and/or mammalian cell culture protein therapeutics. The individual in this role is recognized as a subject matter expert with regard to Quality Assurance and Quality Control.

Quality Assurance Accountabilities

• Raw material release, Quality on the floor, disposition of drug substance
• QA review of quality control data, root cause analysis, risk management
• Deviation, Change Control and CAPA management
• Document/records management, quality metrics reporting, data integrity
• Training management, QA review of method qualification/validation, process qualification/validation
• Equipment/utilities/facilities qualification and continuous improvement
• Partner with Global Quality to ensure internal audits, client audits, supplier quality management, managing regulatory inspections, and quality systems are implemented effectively, efficiently, and compliantly at the site

Quality Control Accountabilities

• Oversight of QC Analytical testing
• Oversight of QC Microbiology tasks including Bioburden, Endotoxin, TOC Conductivity, Water collection Osmolality, EM collection and testing, Organism/Media QC, EM Trending, Sample Accessioning, and Raw Material Program Management
• Knowledge of 21CFR210, 211 required

Cross-functional Partnerships

Collaborate with site operations (Manufacturing, Facilities & Engineering, Supply Chain, EHS&S, and Operational Excellence) to ensure appropriate quality oversight. Partnership with the Operations and Site Head is crucial to ensure the site’s success. In consultation with the SVP of Quality and Regulatory, the Senior Director of Quality, Quality Site Head holds final accountability for and decision making on the matters relating to GMP compliance for the site.

Responsibilities

• Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product
• Ensure the site is inspection ready at all times
• Collaborate with other Quality Site Heads on continuous improvement initiatives
• Lead, assess, mentor, and develop departmental associates
• Manage performance; ensure team meets expectations and objectives; guide professional growth via personal guidance and training
• Key contributor to long-term strategic planning and part of senior leadership team
• Work with internal and client teams to establish Quality strategy, define roles, and problem solve

Minimum Requirements

• Bachelor of Science degree in a scientific discipline with 8 years of quality management experience plus at least 5 years’ experience serving in a relevant technical management capacity required
• Master’s degree with 6 years or a PhD with 4 years of quality experience would be considered
• At least 15 years of regulated pharmaceutical industry experience
• CMO experience preferred
• Thorough knowledge of cGMPs and biotechnology-derived product regulations
• Demonstrated track record in regulatory inspection management, strong orientation for Quality and Customer Service, strong collaboration and team building skills, support attainment of aggressive growth and profit objectives by ensuring adherence to Quality Systems as required by various regulatory bodies, demonstrated level of respect for individuals, high level of integrity and personal responsibility, record of innovation
• Experience developing, implementing, and executing strategic plans and objectives for organizations and departments

Skills

• Ability to read, analyze, and interpret the most complex documents
• Ability to respond effectively to the most sensitive inquiries or complaints
• Ability to write speeches and articles using original or innovative techniques or style
• Ability to make effective and persuasive speeches and presentations on controversial or complex topics to senior management peer group, employee groups, customers, and/or the boards of directors
• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
• Ability to understand and interpret nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases
• Ability to deal with a variety of abstract and concrete variables
• Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations
• Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis
• Ability to sit or stand for long periods of time
• Ability to use a computer, telephone, spreadsheets, PowerPoint, Outlook

Pay

Range: $205,000.00 / yr – $283,000.00 / yr