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Director, Quality

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply 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 in Kansas City, MO is hiring a **Director of Quality** . The Director of Quality leads the quality unit at the site and is responsible for setting the strategic direction, properly staffing, and maintaining the Quality Management Systems (QMS) to assure the site is compliant with regulatory (21 CFR Parts 4, 201, 211, and 820), Corporate, and customer requirements. They are responsible for establishing and maintaining the site metrics, management review, and building a Patient First culture at the site. The Director of Quality is responsible for providing project guidance and support and work with customers to resolve quality concerns as appropriate. They will be responsible for operational and compliance performance across regulatory authorities and markets while meeting expectations necessary to drive growth and customer satisfaction.

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

+ Serve as the site's primary contact (with both customers and regulatory agencies) for the site Quality Unit ensuring expectations are met consistently and at a high level. Ensures the site meets requirements for drug and combination product manufacturing across product technologies including Biologics and Analytical Services.

+ Develop and implement Site Quality Plan, Quality Unit objectives and related procedures.

+ Maintain an effective Quality Management System (QMS) that aligns with regulatory requirements/expectations.

+ Monitor site compliance to FDA, EU and all other applicable requirements.

+ Direct a team of Quality professionals. Provide development and disciplinary actions (as needed) to assure the department remains engaged and motivated.

+ Ensure regulatory and customer audits are managed successfully and any responses submitted in a timely manner.

+ Approve or reject, starting materials, packaging materials, and intermediate, finished products, and to evaluate batch production records.

+ Ensure that all necessary QC testing is performed on manufactured products supporting and meeting business objectives and on-time deliveries. Ensure Quality approval of specifications, sampling instructions, test methods and other Quality Control procedures.

+ Other duties as assigned.

The Candidate

+ Bachelor's Degree Required (scientific field preferred). Master's Degree in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology preferred.

+ 10+ years’ experience in pharmaceutical industry with increasing levels of responsibility and leadership in quality assurance, compliance and quality control.

+ Experience leading Quality Operations at a manufacturing site operation for 3 years at a minimum (e.g. Quality Operations, QC Operations, Manufacturing) is required.

+ Strong understanding of the functional areas of manufacturing, sourcing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment

+ Must have a demonstrable record of implementing and maintaining a total quality system; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics.

+ Experience with Biologics / sterile drug product manufacturing is strongly preferred.

+ Proven ability to lead a large, multi-level/multi-shift organization (e.g. 50+ employees) effectively.

+ Knowledge of cGMP, ICH, and other non-US regulations / guidelines; demonstrated experience applying them to both cGMP manufacturing and/or QC lab environments.

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

+ Tuition Reimbursement

**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 [email protected] . 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 [email protected] 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) .