Job Description

Quality Assurance Operations Supervisor

Essential Duties and Responsibilities

• Overall responsibility for coordinating the disposition of API and drug product
• Coordinates batch documentation review with Operations groups to ensure GMP compliance and timely delivery of products to customers
• Ensures all documentation and API/drug product batches produced meet the requirements of GMPs and other regulatory health authority requirements
• Supervises day-to-day functions of the QA Operations team
• Mentors/coaches and provides succession planning for direct reports
• Ensures batches meet GMP requirements and all production and QC documentation has been reviewed prior to disposition
• If any errors or data integrity issues occur during the manufacturing, packaging, labelling, and testing of API/drug product, that they have been investigated according to internal procedures.
• Ensures QC data meets specifications and any OOSs are investigated per internal procedures
• Provides QA presence on API/drug product filling/packaging line through documented walkthroughs to ensure GMP compliance
• Works with global partners in EU/UK QA to ensure batches are dispositioned and records provided in a timely manner
• Manages drug product complaint program ensuring samples are received in a timely fashion and investigations meet established internal procedural requirements and reports back to customer service team through approved software programs
• Prepares metrics for weekly, monthly and quarterly Management meetings

Key Competencies (knowledge, skills, and abilities every person must possess to be successful), i.e.

• Critical Thinking skills using “Risk Based” logic and reasoning to identify the strengths and weaknesses in QMS, recommend and institute solutions, conclusions, and approaches to problems
• Demonstrated ability to evaluate quality matters by leveraging GMP experience, analyzing data, while using FDA Risk Based type approaches
• Attention to detail/ sense of urgency- ability to act quickly and escalate issues
• Excellent customer service skills and professional demeanor always to interface effectively with all internal and external customers
• Excellent verbal and written communication skills
• Energetic, enthusiastic, and motivational disposition

Education/Experience

• Bachelor’s degree required with Bachelor of Science preferred
• 5+ years’ experience in Pharmaceutical/Biotech industry
• Experience in TrackWise, EDMS, LMS or other such software tools for managing the QMS
• Working knowledge of 21 CFR part 210/211, and part 11, FDA guidance. Knowledge of 21 CFR part 820 Medical Device Regulations preferred.

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