Catalent Pharma Solutions Director, QA Development in St. Petersburg, Florida

Job Description

Position Summary

Catalent is looking to recruit a Director, QA Development to join a growing Quality team in St. Petersburg, FL.

The Director, QA Development will be responsible for directing the validation and QA team responsible for product development and analytical development activities. This position will ensure the compliant and seamless flow of activities from development through validation and provide additional oversight during product launches.

Additionally, the Director, QA Development will: work directly with QA and validation managers to improve processes and procedures with respect to the development and validation of products within the facility; be responsible for ensuring the site is in compliance with cGMP guidelines, adherence to Catalent Corporate Quality Policies, and applicable Catalent Pharma Solutions quality standards across the area of focus; partner with other functional areas (e.g. Product Development, Operations, Customer Service, Quality Control, etc.) to ensure continued compliance for the area/site; continually review and assess the overall design, administration, and implementation of the site Validation Program (including but not limited to cleaning, computer, equipment, facilities, and process validation activities).

In concert with Catalent’s Patient First philosophy, this role is paramount to ensure the efficacy and quality of our softgel development and manufacturing processes which will ultimately yield safe drug products for patients.The St Petersburg site is Catalent’s primary softgel development and manufacturing facility in North America with capacity of 18 billion capsules per year. The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates.

The Role

  • Ensure Quality systems are compliant with corporate and site procedures as well as regulatory and industry standards

  • Drive continuous improvement initiatives, participate/lead Regulatory Inspections and Customer Audits, provide Subject Matter Expertise to the functional areas of QA, and recommend process changes as a result of trends from CAPA/Complaints/Investigations

  • Serve as the Quality liaison for clients and internal customers and become the owner or escalation point for client requests/issues; maintain, develop, and nurture the client partnership to ensure alignment and consensus; review quality metrics, trackers, and reports to characterize the health of the client relationship and state of quality systems

  • Provide support to internal, client, and regulatory audits; engage in monitoring systems to maintain awareness and audit/inspection readiness at all times

  • Provide support for Field Alert and Recall activities initiated by site or Customer as directed by Director of Quality and Regulatory Affairs

  • Interface with regulators during inspections; provide regulatory compliance oversight in areas like DEA, Food Safety, and State of Florida regulations

The Candidate

  • Bachelor’s Degree required in science major (Chemistry, Biology, or Microbiology preferred); advanced degree preferred

  • Minimum of 7-10 years of progressive experience within a quality organization to include validation experience, the ability to multitask, and demonstrated diplomatic skills

  • Must possess experience in supporting or leading development activities (QA or hands on development experience)

  • Previous experience in a laboratory environment (Analytical Research and Development or QC) is preferred

  • Prior experience working with validation or technical services preferred

  • Proven experience working with customers; contract manufacturing experience preferred

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develop

Position Benefits

  • Opportunity to be a change agent and drive improvements within a dynamic Quality team

  • Defined career path and annual performance review & feedback process

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

  • 26 days of paid time off annually + 7 paid holidays

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 offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.

Why Catalent?

  • Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.

  • We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.

  • Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.

  • Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.

  • Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.

  • We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.

  • We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.

  • Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.

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.