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Manager, Quality Systems Audit

Position Summary

Catalent is a global, high-growth, public 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.

Catalent’s 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. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.

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.

This position is 1st shift M-F 8AM-PM and 100% on site at Harmans/BWI, Maryland facility.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

The Role:

▪ 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.

▪ 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 .

▪ 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.

▪ 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.

▪ 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.

▪ 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

▪ 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

▪ Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.

▪ Other duties as assigned.

The Candidate:

▪ Masters’ degree in a Scientific, Engineering or Biotech field with 6 - 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 OR Bachelor’s degree in a Scientific, Engineering or Biotech field with 8 - 10 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 – 4 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict.

▪ 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

▪ 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.

▪ 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.

▪ 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.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

• Dynamic, fast-paced work environment

• Generous 401K match and Paid Time Off accrual

• Medical, dental and vision benefits effective day one of employment

• Tuition Reimbursement

• Wellhub program to promote overall physical wellness

• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .