Catalent Pharma Solutions Associate Director, Quality Assurance in Winchester, Kentucky

Job Description

Associate Director, Quality Assurance

Position Summary

The Associate Director, Quality Assurance reports to the Director of Quality.

The Associate Director Quality Control is responsible for providing leadership and Quality Assurance Management support within each of the Business Units at Catalent’s Winchester site. This individual will have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control and Customer relations.

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. He/She 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

  • He/She will have proven ability to maintain strong relationships with customers, regulatory organizations and other industry contacts

  • Ensure Quality systems are compliant with corporate and site procedures as well as industry standards such as but not limited to Annual Product reviews, Complaints, Investigations and root cause analysis, Corrective and Preventive Actions, and Training

  • Manage the Batch Disposition team

  • Participate in Regulatory Inspections and Customer Audits

  • Propose, implement and enforce quality improvements

  • Proven ability to manage multiple complex regulatory projects

  • Supervising and mentoring junior staff

The Candidate

  • Minimum Bachelor of Science, MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology with 10+ years experience in pharmaceutical operations.

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

  • Prior experience and knowledge of quality assurance and quality control as it relates to pharmaceutical dosage forms is preferred.

  • Experience in international regulatory compliance is considered a plus

  • Experience in supervising and developing staff

Position Benefits

  • Works cross-functionally and receives exposure to several departments

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

  • 19 days of paid time off annually + 7 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

About Catalent

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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.

Catalent 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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!

Grow with us. Be challenged. Make a personal impact.

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

Catalent 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, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.