Manager, Quality Systems Audit

Manager, Quality Systems Audit

Position Summary:

Catalent is a global, high-growth company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Catalent Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.

The Manager, Quality Systems Audit is responsible for the management and oversight of the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, compiling, trending and reporting key quality metrics for Senior Management review, and other quality system functions, as needed.

The Role:

1. Manages the QA staff supporting Investigation/Deviation/CAPA Management, Change Control, Risk Management, Quality Metric Tracking responsibilities; ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines; build effective teams that apply their diverse skills and perspectives to achieve common goals; oversee daily activity for the group to ensure quality results Performance management for direct reports.
2. Responsible for and administers Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution; responsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of commitments; perform trending review of deviations and investigations, compile report and identify trends or areas requiring additional actions.
3. Responsible for and administers the change control system for tracking and coordinating the initiation, execution and completion of change controls; responsible for and administers the Risk management system and track completion of risk assessments.
4. Compile pertinent QA metrics for Senior Management review; assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track action items for completion.
5. Support client projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trials; potential work with clients during initial and subsequent manufacturing campaigns; supports regulatory (FDA, EMA) and client audits/inspections of Catalent; assists with performing internal audits.
6. Maintains databases and systems used for tracking various GMP manufacturing associated support activities; assists with the generation and/or revision of GMP documentation such as standard operating procedures; continually evaluates systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards.
7. Works closely with manufacturing, Facilities and Quality Control staff to resolve quality issues with regard to the facilities and product manufactured; works closely with other departments at Catalent and offer assistance as needed.
8. Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.
9. Other duties as assigned.

The Candidate:

1. Masters degree in a Scientific, Engineering or Biotech field with 6 years experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation OR Bachelors degree in a Scientific, Engineering or Biotech field with 8 years experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in a Quality Assurance/Quality Control function with a strong familiarity of general GMP documentation.
2. 2 years Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.
3. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
4. Experience with Good Manufacturing Practices (GMPs) and 21 CFR Parts 210 and 211 OR Quality System regulations (QSR) per 21 CFR Part 820; ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable; expert knowledge of biological regulations (21 CFR Part 600s) or EU GPs, a plus; have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
5. SME/Expert in all Microsoft Applications i.e. EXCEL, PowerPoint, Access, Teams and Sharepoint; proficient with electronic systems, including developing and producing reports; experience with data analytics and concepts.
6. Ability to work in fast paced environment supporting the quality assurance/quality control departments of a CMO for Phase I/II/III GMP manufacturing of biologic bulk drug substance and sterile finished drug product. Experience supporting Federal government contracts is a plus.
7. Ability to quickly learn and navigate new electronic systems; able to work in a team setting and independently under minimum supervision; creative individual with excellent trouble shooting skills; requires the ability to produce results in a fast-paced environment to meet client deadlines.