Catalent Pharma Solutions Supervisor, Quality Assurance -Client QA in Baltimore, Maryland
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
Catalent Gene Therapy is looking to recruit a Supervisor, Quality Assurance-Client QA to join our growing team in Baltimore, MD.
The Supervisor, Quality Assurance-Client QA is responsible for providing Quality Assurance oversight of Catalent Cell and Gene Therapy’s Quality Operations Client QA to ensure compliance with applicable US/EU regulations, guidance's, industry standards and Catalent policies/procedures supporting the Phase I/II clinical GMP manufacturing of biological drug substance and drug product. The position will provide continuous improvement support to Client QA and some Quality on the floor activities, batch disposition and serve as the key quality resource for the Program management and manufacturing organization.
Catalent Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
Facilitates QA support and works closely with other Catalent functional units including Manufacturing, MS&T, Validation, Facilities Engineering, Pre-Clinical and Quality Control to assess and resolve quality issues with regards to Client interaction, the facility, and products manufactured.
Serve as the QA liaison with the Manufacturing organizations to support company goals, client projects, continuous improvement initiatives and as a general resource.
Ensure current Good Manufacturing Practices (cGMPs) compliance for clinical manufacturing of phase I/II/III investigational biological product, and compliance to applicable regulations and industry guidance.
Work with management and employees to help initiate new client projects, maintain current client projects and provide support team.
Author, review and approve documents such as SOPs as they relate to Quality Operations Program.
Execute objectives, identifying continuous improvement initiatives to gain efficiency and increase right the first time (RFT) score, monitors progress of deliverables,
Collaborates with manufacturing and program management to ensure quality objectives are attained related to client projects and internal projects.
Develops and implements procedures, programs and policies that support GMP operations and industry best practices.
B.S. in a Life Sciences, Engineering or related discipline and 5+ years of relevant experience - OR - M.S. in a Life Sciences, Engineering or related discipline and 3+ years of relevant experience, Minimum of 1 year supervisory experience preferred
Experience within the biologic, pharmaceutical or medical device industry performing direct hands-on work in
a Quality Assurance, Quality Control, Environmental Monitoring or Validation function with a strong familiarity of general GMP documentation and Equipment/Instrumentation.
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Exposure to 5S and lean sigma desirable
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Potential for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross functional exposure to other areas of within the organization
Medical, Dental, Vision, and 401K are all offered from day one of employment
19 days of paid time off annually + 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 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, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. 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.
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!
personal initiative. dynamic pace. meaningful work.
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.