Director, Quality at Catalent Boston

Kansas City, Missouri, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Aug, 26

Salary

0.0

Posted On

31 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Regulatory Compliance, Site Leadership, Global Quality Strategy, cGMP Regulations, Validation Principles, Performance Management, Internal Investigations, Audit Coordination, Process Harmonization, Strategic Planning, Operational Excellence

Industry

Pharmaceutical Manufacturing

Description

Director, Quality Position Summary: 100% on-site Catalent’s Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects. Catalent Pharma Solutions is hiring a Director of Quality in our Clinical and Specialty Services division who will have a focus on Global Leadership, Site Leadership, Department Leadership and Personal Leadership. This is a Senior Quality Assurance leadership role in a fast-paced, customer-focused organization. The Role: Global Leadership: Working with the BU VP Quality and the other CSS Quality Directors to create and implement Business Unit quality strategy, global quality policies, BU quality process harmonization, etc. Site Leadership: As a member of the Site Leadership Team working with the General Manager to create and sustain a site culture of Safety, Quality Performance, Operational Excellence, Continuous Improvement, Error Reduction, Regulatory Compliance, and sound fiscal responsibility. Lead the development of site Quality Objectives, site Quality Plans, Quality Management Reviews, etc. Department Leadership: Overall responsibility for the site Quality Assurance and regulatory compliance functions. Oversee and execute all Performance Management Program (PMP) actions for the site Quality Assurance department. This includes professional development counseling, informal and formal performance appraisals and feedback, and talent development/success planning. Responsible for internal investigations on cGMP issues, trends and customer complaints. Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity. Responsible for process integration and procedural harmonization with other CSS sites. Accountable for customer and Regulatory Audits, including coordination and submission of Catalent responses. Other duties as assigned. The Candidate: BS Degree (or regional equivalent) in a Science, Engineering or Pharmaceutical discipline required. 10+ years of experience working in a chemical, pharmaceutical, food or relevant industry with 5+ years experience in QA/RA areas with progressive responsibilities. Experience in managing people, providing leadership, and implementing developmental plans for personnel. Direct experience and working knowledge of Validation principles, including validation of processes, equipment, systems, analytical methods, cleaning and transportation. Working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies. Must have a demonstrable record of implementing and maintaining quality systems, laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience. Why You Should Join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment 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 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.

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Responsibilities

The Director of Quality is responsible for overseeing site Quality Assurance and regulatory compliance functions while collaborating on global quality strategies. Key duties include managing internal investigations, approving GMP documentation, and leading site quality objectives and audits.