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Manager, Supplier Quality

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, Supplier Quality is responsible for the management and oversight of the core quality systems related to Supplier Quality Management, including supplier qualification, quality agreements, audits, complaints, CAPA tracking, supplier change and alert notifications and risk management. This role is also responsible for compiling, trending and reporting key Supplier Quality metrics for Senior Leadership review. This role may also engage on all aspects of raw material management including material qualification, specifications, reduced testing programs and warehousing practices. This role manages the Supplier Quality team which supports all Catalent Gene Therapy sites.

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, coaches and develops the QA staff responsible for Supplier Quality Management across the Catalent Gene Therapy sites.

• Engages with the global SQM team to assure Gene Therapy sites comply with all corporate Catalent policy and standards requirements for supplier quality; negotiates supplier quality agreements on behalf of Gene Therapy sites to assure compliance with Catalent expectations; manages & advises team assessing supplier quality alerts and change notifications to determine impact to user sites within the expected turn-around time

• Manages Gene Therapy Supplier Audit Schedule and Annual audit planning; tracks Supplier Complaints and CAPA to closure in a timely manner; responsible for managing BU use of the Global TrackWise Supplier quality modules; responsible for and administers the Risk management system and track completion of risk assessments

• Assembles critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Leadership on a periodic basis. Track action items for completion; compiles pertinent QA metrics for Senior Leadership review

• Aids improvements and process mapping of all supplier quality related processes, updating SOPs and simplifying supplier management tools as needed.

• Engages in Materials Management continuous improvements and efficiencies including materials qualification, sampling processes and reduced testing programs; supports client sourced materials/supplier qualifications as needed. Facilitates the process for movement of client sourced materials into the Catalent Supplier Management systems

• Continually evaluates systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards; creates and/or revises procedures and tools associated with simplification of SQM policies for Gene Therapy

• Other duties as assigned

The Candidate:

• B.S. in a Life Sciences discipline and 10+ years of relevant GMP experience required, CMO/CDMO experience preferred

• 2 – 4 Progressive Leadership experience, experience with Performance Management, Goal Setting and Managing through Conflict

• Experience within SQM role preferred, specifically in auditing and quality agreement negotiation highly desirable; 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 with GMP Quality Systems and documentation; experience with global Audit guidelines

• Experience with Good Manufacturing Practices (GMPs) and 21 CFR part 11; ASQ CQA (American Society of Quality Certified Quality Auditor) highly desirable

• Experience within Quality Risk Management and Risk assessments.

• Expert with electronic systems, including TrackWise, and MasterControl and ability to create queries and reports from these systems

• SME/Expert in all Microsoft Applications i.e. EXCEL, PowerPoint, Visio and experience creating metrics

• Able to work in a team setting and independently under minimum supervision; creative individual with excellent trouble shooting skills; positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to the corporate and local teams; ability to succeed in a team-oriented environment under very dynamic conditions; able to demonstrate understanding and adherence to Catalent policies, safety procedures and the cGMPs

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) .