QA Manager

Fagron•Canton, MA

12d

About The Position

The QA Manager directs and manages quality assurance functions related to validation, training, and documentation, and works with Corporate Quality to help ensure the site complies with regulatory and corporate requirements. The position is responsible for final product release and for administering compounding quality assurance and compliance to support company objectives, production, and timely new product introductions. The role manages the validation, training, and documentation control functions, with indirect responsibility for quality assurance interpretations of quality problems in QC. It administers, reviews, and approves corporate policies and quality-system documentation; provides cGMP guidance to production departments; oversees deviation investigations and CAPA completion; and directs product complaint investigations. The QA Manager also participates in regulatory inspections, leads inspection preparation and follow-up, and has authority to make decisions for the facility QA department. The position manages personnel and budget, plans for future resource needs, supports major projects and continuous improvement, and develops employees in quality roles.

Requirements

Bachelor of Science degree.
At least 5 years of related work experience, including at least 3 years of supervisory experience.
Advanced training or experience in cGMPs and GLPs.
Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events, and to determine whether events suggest a product quality issue.
Ability to interpret large amounts of safety- and quality-related data and recognize or identify potential health hazards through signal detection.
Ability to prioritize and multitask with minimal supervision.
Knowledge of PC systems and Microsoft Office Suite, including Word and Excel.
Excellent written and verbal communication skills.
Strong working knowledge of regulatory and ISO requirements in the parenteral pharmaceutical industry, as well as other legal requirements for business operations.

Nice To Haves

Advanced degree strongly preferred.
Lotus Notes experience preferred.

Responsibilities

Administer compounding quality assurance and compliance to support company objectives, production, and timely new product introductions.
Review procedures for quality systems, validation, change control, manufacturing discrepancy investigations, cGMP and regulatory compliance, and product specifications.
Participate in regulatory inspections of the compounding facility, including FDA inspections; provide or obtain information requested by inspectors.
Manage the team of pharmacists responsible for final product release.
Manage validation, training, and documentation control functions, with indirect responsibility for QA interpretations of QC quality problems.
Administer, review, and approve corporate policies related to standard operating procedures, validation documentation, and manufacturing discrepancy reports.
Provide cGMP guidance to departments involved in pharmaceutical production.
Ensure deviation investigations are appropriately investigated and recorded, and drive CAPA items to timely completion.
Make decisions for the facility QA department in internal and external meetings and assume responsibility for daily functional activities.
Lead major projects, including new products and facility renovations, and support continuous improvement initiatives.
Manage administration of the Quality system in the Quality Organization.
Develop personnel, administer the budget, and plan for future personnel, equipment, and facility resource needs.
Direct investigations of product complaints for manufactured products and ensure appropriate documentation is completed.
Interact with the US regional Medical Affairs and Vigilance Department as needed.
Schedule and conduct pre-inspection reviews of operations and follow up where corrective action is required.
Develop employees to improve their performance in quality professional duties.