Manager, QA

Manager, QA

The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support within Catalent's St. Petersburg site. The Department has the responsibility for Quality aspects including but not limited to Quality Systems, Finished Product Batch Release, Training, Internal/External Audits, Complaints, APR, Investigations, Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure of the Quality Unit and could include all or some aspects of the Quality function.

Position Summary

The QA Manager is responsible for managing aspects of Quality Assurance representing a staff of approximately five to ten associates which includes QA Product Managers responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: change controls, material/product specifications, test methods, product process validation and cleaning validation documents.

The Role

• Manages team routinely engaging in client interactions and client audits and participates in those activities as needed
• Function as the Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives.
• Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, corrections, and effectiveness checks.
• Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
• Reviews and approves technical documents, such as, but not limited to: Technical Services Protocols and Reports ,Process Validation Protocols and Reports, Cleaning Validation Protocols and Reports, IQ/OQ/PQ Protocols and Reports, Material and Product specifications; Test methods; Master Batch Records; and Master Shipper Labels.
• Engage in monitoring quality systems to maintain awareness and audit/inspection readiness at all times.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• All other duties as assigned

The Candidate

• Bachelor's Degree Required
• Bachelor's Degree in Science (Chemistry, Microbiology or Biology preferred) preferred however relevant years of experience will be considered;
• A minimum of five years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
• Experience working with customers - Contract manufacturing experience preferred
• Prior experience working with validation or technical services preferred.
• Proven ability to multi-task and demonstrate diplomatic skills.
• Must possess excellent English verbal and written communication skills.
• Intermediate to proficient skills in Microsoft Office applications
• Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I
• Employee Stock Purchase Program
• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• Generous 401K match
• 19 days accrued PTO + 8 paid holidays

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 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 [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.