Sr. Manager Quality Systems & Compliance
About The Position
The Manager, Quality Systems is responsible for overall management of Quality Systems at the site. The incumbent ensures that Quality Assurance (QA) activities are conducted in compliance with Current Good Manufacturing Practices (cGMP). Makes sure that all SOPs and applicable regulations are followed. To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. • Shall adhere to all regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices. • Consistent support and practice of all Ash Stevens mission and values.
Requirements
- Bachelor's degree in the physical or biological sciences or engineering. Chemistry/Chemical Engineering preferred.
- Minimum ten (10) years experience in pharmaceutical operations, regulated life sciences, or quality assurance with 2-5 years supervisory experience.
- Minimum five (5) years experience in QA leadership.
- Knowledge of GMP requirements (21 CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
- Strong computer skills with Microsoft Office, databases, reporting and statistical tools.
- Proficient in TrackWise, SAP and MasterControl.
- Excellent organizational and planning skills.
- Strong written, verbal and interpersonal communication skills.
- Ability to develop, perform, evaluate and troubleshoot within a scientific discipline.
- Strong analytical skills and ability to work independently against multiple deadlines.
- Experience interacting with FDA or other regulatory agencies.
- Knowledge of manufacturing quality, validation, SPC, facilities and critical systems.
- Must complete tasks independently and notify supervisor of decisions outside established processes.
Responsibilities
- Support internal and external audits and regulatory inspections.
- Conduct audits, inspections and walkthroughs, ensure corrective actions, represent quality systems during audits, participate in responses, maintain QA retain inventory and perform annual retain inspections.
- Prepare or review Annual Product Reviews, Non-Conforming Material Reports, Investigation Reports and validation documentation.
- Oversee CAPAs, document reviews, environmental monitoring, quality metrics, quality agreements, TrackWise events, deviations, OOS/OOT investigations, procedure maintenance and gap assessments.
- Perform routine and ad hoc quality systems reporting, trend analysis and management review support.
- Participate in risk management activities and maintain appropriate risk documentation.
- Manage the QA Systems team, training activities, training records and training module development.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
