Quality Assurance Manager

Job Description

·         Evaluate and implement systems, methods, techniques, and solutions to complex quality compliance issues.

·         Host all regulatory agency and client audits.

·         Interface with Clients for project planning, and problem resolution with a strong customer service approach.

·         Recommends and leads implementation of critical compliance systems and provide recommendations to operations management.

·         Recommends the stop of any manufacture and/or distribution of a product if necessary.

·         Manages the review, approval, and delivery of Quality Assurance related training content and programs including new Quality Assurance initiatives for continuous improvement.

·         Analyses trends associated with data, proficiency testing, equipment/supply/reagent defects and develop solutions as appropriate.

·         Directs and advises the Quality Assurance group to achieve long and short term goals and objectives.

·         Develops, improves, and revises Standard Operating Procedures (SOPs) and Quality Policies as required/needed.

·         Assures the qualification of suppliers and vendor management program.

·         Ensures the review and approval of equipment qualification protocols and results.

·         Participates in internal auditing programs to assure compliance with regulatory requirements and company standards.

·         To carry out any other duties which are within the employee’s skills and abilities whenever reasonably instructed.

Qualifications

BS in Chemistry or equivalent; MS in Chemistry preferred and 7 years of experience in Quality Assurance in an FDA regulated industry

3 plus years of supervisory experience

Knowledge and previous experience with GMP, ICH Q7, and 21 CFR Part 11

Expertise in FDA regulations, GMPs, and Quality Systems relevant to the manufacture of pharmaceuticals

Additional Information

Skills/Experience Valued but not required:

·       Experience in a cGMP environment

·       Experience or familiarity with Labware LIMS and the Instrument Manager module

·       Experience or familiarity with Master Control and Trackwise

·       Recent relevant experience in bulk pharmaceutical/API manufacturing or specialty chemicals

Veranova is an Equal Opportunity Employer. It is the policy of Veranova to provide equal employment access and opportunity to all persons regardless of age, race, color, national origin, religion, sex, sexual orientation, gender identity and/or expression, physical or mental disability, genetic information, citizenship, marital status, veteran status, or any other characteristic protected by federal, state or local law.

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