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Catalent Pharma Solutions Quality Director in Winchester, Kentucky

Job Description

Position Overview:

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here (

Quality Director

The Quality department fulfills a critical role in the daily activities at the Winchester facility. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent Pharma Solutions complies with all applicable regulations and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration (21CFR parts 210/211, 820 and 1300s), state boards of pharmacy, US Drug Enforcement Administration, European, South American, Japanese, and Australian agencies and other international and/or local health authorities.

The Director of Quality leads the quality unit at the site and is responsible for operational and compliance performance that meets expectations necessary to drive growth and customer satisfaction. The role will be responsible for building a high performing team and systems by addressing all current and future needs and building short and long-term quality plans for the site.

Catalent's Winchester location is the flagship US manufacturing location for large scale complex controlled release (CR) oral dose forms, with integrated analytical and development services. With 20 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry leading Glatt technology. This site offers newly installed Fluid Beds, expanded analytical labs, and an advanced open facility design that provides flexibility in supporting the requirements of any new customer program.

The Role

  • Develop, implement and communicate a clear strategic vision for quality to maximize employee focus and develop a competitive advantage. The Director of Quality will maintain the highest degree of product quality and quality systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. The successful candidate will bring an expert-level understanding of quality principles and regulatory knowledge.

  • The Director of Quality will have proven ability to maintain strong relationships with customers, regulatory organizations and other industry contacts. This will enable the incumbent to anticipate changes in the quality/ regulatory climate, and redesign processes accordingly. It is crucial that this individual quickly gain the credibility and respect of his/her team, customers, and the senior executives of other functional areas within the site and Company, particularly with operating leadership. This will require the ability to satisfy the twin needs of compliance and productivity.

  • Lead a team of approximately 120+ department personnel and have overall responsibilities for Quality Control, Quality Assurance, Regulatory Compliance, and Validation. Must have a demonstrated track record of talent management; building bench strength and setting clear objectives for performance and accountability.

  • Responsible for the quality aspects associated with materials management, manufacturing, packaging, storage and release of all products produced at the site. The Director of Quality is also responsible for compliance to global standards of cGMP.

  • Leads Quality Strategic Planning and Quality yearly objective setting that meet compliance requirements and business needs.

  • Assures that systems are in place in all areas of technical operations to achieve compliance with cGMP regulations and corporate quality standards.

  • Oversees laboratory operations, responsible for testing/inspecting and releasing materials for use in product manufacturing and packaging and final product testing.

The Candidate

  • Minimum Bachelor of Science, MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology with 10+ years’ experience in pharmaceutical quality assurance, compliance and quality control.

  • Experience in the development of innovative and action-oriented quality programs are critical.

  • 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.

Position Benefits

  • Works cross-functionally and receives exposure to several departments

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 26 days of paid time off annually + 8 paid holidays

Leadership Competencies for Performance and Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.

C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 . 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking ( for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here ( .