Director, Quality Control

Responsibilities

• Direct the Quality Control department.
• Schedule and oversee testing and operations of quality control team(s) responsible for samples and incoming, in-process and final product testing.
• Coach and mentor QC analysts, support troubleshooting activities and investigations.
• Ensure QC laboratory operations are cGMP compliant.
• Oversee QC equipment qualification, maintenance and calibration programs.
• Ensure QC procedures, practices and analytical methods are in compliance with the applicable compendial, regulatory and customer requirements.
• Conduct thorough QC investigations.
• Support production and proper life-cycle of test methods (i.e. validation, transfer, review, approval, changes).
• Manage OOS/OOT investigations.
• Drive stability programs and ensure compliance to the applicable compendial, regulatory and customer requirements.
• Ensure compliance of the laboratory operations to the most current data integrity requirements.
• Implement industry best practices in the QC laboratories to maximize efficiency while maintaining a high compliance level.
• Interact with internal and external customers.

Requirements

• Education and Experience: Bachelor’s degree in Biology, Microbiology, Chemistry or related field. Minimum ten (10) years’ experience in the pharmaceutical industry in drug substance or drug product manufacturing, including eight (8) years’ experience in Quality Control. Minimum five (5) years’ experience in a professional management role.
• Computer Skills: Proficient in the use of MS Word, Excel, Outlook, and Access.
• Other Skills and Abilities: Combined ability to mentor and coach individuals and ability to motivate teams to reach a common goal. Strong knowledge of cGMP regulations applicable to FDA regulations. Strong knowledge of QC techniques with proven ability to solve complex problems. Strategic thinking. Strong communication skills. Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Qualifications

• Pass a background check.
• Pass a drug screen.

Benefits

(Not specified)

Pay

(Not specified)

Schedule

(Not specified)