Manager, QA

4 weeks ago

Bloomington, United States Catalent Pharma Solutions Full time

We're hiring a 3rd shift Manager, QA to support our inspection and packaging teams at our Bloomington, Indiana facility.

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Manager, QA has oversight of on-the-floor support for inspection and packaging departments. This is a full-time, salaried position and is 100% site based. The schedule is Sunday - Thursday 11:00PM – 7:30AM.

Catalent Biologics in Bloomington, Indiana is a state-of-the art, GMP manufacturing facility, providing one million sq/ft of drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.

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 Role

  • Primary Quality Management contact for inspection and packaging.
  • Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.
  • Manages the oversight, review and approval of deviation investigations and change controls pertaining to CGMP production and testing for a specific production line.
  • Supports the establishment, preparation, and communication of quality metrics for specific production line. Identifies and works with function areas as appropriate to facilitate improvements.
  • Reviews and approves Product Complaints and Product Quality Reviews; tracks and trends product and line performance to drive quality improvements.
  • Interacts and communicates with customers to assure expectations are established, agreed to, and achieved.
  • Takes responsibility for direct reports' performance by setting clear goals and expectations, tracking progress against the goals, ensuring constructive feedback, and addressing performance-related concerns and issues promptly.

The Candidate

  • Bachelor's degree preferred.
  • Minimum of 3 years of leadership experience.
  • Minimum of 7 years cGMP experience, or other regulated industry.
  • Minimum of 5 years providing quality assurance support to cGMP pharmaceutical production, or other regulated industry.
  • Must be able to read and understand English-written job instructions and safety requirements.

Why you should join Catalent

  • Medical, dental, vision, and wellness benefits are effective on the first day of employment.
  • Potential for career growth on an expanding team and organization.
  • 152 hours of paid time off annually plus 8 paid holidays.
  • Community engagement and green initiatives.
  • Engaging D&I Employee Resource Groups.
  • Tuition reimbursement program.
  • Generous 401K match.

​

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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ) .


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