Quality Assurance Manager

General Overview

The position has overall responsibility for internal quality assurance functions, which include batch release and the execution of various quality systems, including Complaints, Events (Deviations and non‑conformances), CAPAs, Effectiveness Checks, Annual Product Reviews, and other quality‑related tasks.

• Serve as the quality subject‑matter expert on all quality matters involving Mission’s manufacturing, packaging, warehousing, and supporting operations.
• Review and approve Mission’s GMP Master documents and oversee the release of manufactured batches.
• Lead the Internal Audit and Supplier Audit Programs.
• Review and approve change controls; facilitate or review and approve deviations, CAPAs, non‑conformances, and customer complaint investigations.
• Communicate any quality matters with Mission’s customers as agreed upon in Quality Agreements.
• Facilitate and host customer audits to support the review of Mission’s manufacturing and quality systems.
• Participate in and support regulatory audits of the facility by the FDA and other health authorities.
• Assist in the coordination and approval of annual product reviews and share approved reports with business customers as required per contract.
• Conduct routine introductory training of new hires on the basic GMP requirements needed for the pharmaceutical industry.
• Work with the Director of Quality Systems and Technical Services on continuous improvement projects for existing processes and quality systems.

To perform this job successfully, an individual must be able to perform each essential duty mentioned satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Innovative Thinking – Looks for creative and innovative approaches/ideas that will improve efficiencies and/or provide solutions to workplace issues or concerns, embraces change, and champions new ideas.

Customer Focused – Demonstrates determination in ensuring that services and/or solutions for internal and external customers meet expectations and needs, incorporating flexibility as needed.

Effective Communication – Communicates appropriately and knowledgeably to effect desired outcomes; presents information clearly and listens to others.

Reliable Team Player – Adds complementary skills and consistently contributes valuable ideas, opinions, and feedback; collaborates well with internal and external teams.

Results Driven – Attains goals and objectives, taking personal responsibility and accountability for own decision making and thinking.

Problem Solving – Identifies and resolves problems in a timely manner; analyses information skillfully; develops alternative solutions and works well in group problem‑solving situations.

Technical Skills – Assesses own strengths and weaknesses, pursues training and development opportunities, continually builds knowledge and skills, and shares expertise with others.

Leadership – Exhibits confidence in self and others, inspires and motivates teams, influences actions and opinions, accepts feedback, and gives appropriate recognition.

Delegation – Delegates work assignments, matches responsibility, provides authority and independence, sets expectations, monitors delegated activities, and recognizes results.

Managing People – Includes staff in planning, decision‑making, facilitation, and process improvement; takes responsibility for subordinates, provides performance feedback, develops skills, solicits and applies customer feedback, and continually works to improve supervisory skills.

Judgment – Displays willingness to make decisions, exhibits sound judgment, supports and explains reasoning, includes appropriate people in decision‑making, and makes timely decisions.

Bachelor’s Degree and at least 5 years of related experience and/or training; or equivalent combination of education and experience.

Supervises employees and carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance, rewarding and disciplining employees; addressing complaints and resolving problems.

Ability to read, analyze, and understand common scientific and technical journals, financial reports, and legal documents; respond to complex or difficult inquiries or complaints from customers, regulatory agencies, or members of the business community; write speeches and articles for publication that conform to prescribed style and format; and effectively present information to top management, public groups, and/or boards of directors.