Manager, Quality Assurance

Company: Disability Solutions
Location: Saint Petersburg
Posted on: September 28, 2024

Job Description:

Manager, Quality AssurancePosition SummarySt. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. --Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. 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 Manager, Quality Assurance 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. Responsible for ensuring the site is following cGMP guidelines, adherence to Catalent Corporate Quality Policies and applicable Catalent Pharma Solutions quality standards across the area of focus.-- Position requires partnership with other functional areas (e.g. Product Development, Operations, Customer Service, Validation, Quality Control, etc.) to ensure continued compliance for the area/site. The Manager, Quality Assurance will provide directional support and as required, hands on, leadership to drive actions and enhancements to the QMS.The Role

• Ensure Quality systems are compliant with corporate and site procedures, regulatory requirements and industry standards for systems such Deviation investigations, Batch record review, Equipment/Facilities, root cause analysis, Corrective and Preventive Actions.
• Oversees Deviation investigation system to ensure timely closure of deviations, corrective actions, effectiveness checks, etc.
• Ensures investigation teams conduct thorough root cause analysis, identifies and implements corrective and preventive action plans to eliminate repeat observations and reviews/approves deviation investigations.
• Function as the Quality department liaison and subject matter expert to other department representatives, customers and regulatory representatives
• Quality liaison for clients and internal customers. Direct reports manage daily client interactions.-- Is expected to become the escalation point for client requests/issues.
• Participates in R&D/Technical Services/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.
• Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA regulatory guidelines).
• 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.
  • Demonstratable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be in place of external experience.
  • 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.
  • Prior quality assurance experience is required.
  • Working knowledge of cGMPs and/or OSHA regulations required. Prefer experience in multiple regions (e.g EU, ANVISA, FDA, Etc.)
  • 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--
    • Competitive medical benefits and 401K--
    • 152 hours of PTO + 8 Paid Holidays--
    • Dynamic, fast-paced work environment--
    • Opportunity to work on Continuous Improvement ProcessCatalent 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 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 . 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, St. Petersburg , Manager, Quality Assurance, Executive , Saint Petersburg, Florida