Associate Director, Quality Assurance

Catalent Pharma Solutions in Severn, MD

  • Type: Full Time
position filled
Job Description Position Overview: 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 Position Summary The Associate Director, Quality Assurance will be a part of the Gene Therapy business responsible for overseeing the QA Client Services and Operations function supporting commercial manufacturing processes. QA Client Services and Operations includes; managing commercial manufacturing projects for the QA department, oversees the batch disposition function, incoming material and product specifications, responsible for assessing quality related issues, and ensuring compliance with applicable regulatory and industry standards for phase appropriate GMP manufacture of biological products. The Role: + Develops and leads by example a team of client facing and "on the floor" QA Associates + Ensure current Good Manufacturing Practices (cGMPs) compliance for commercial biological product, and compliance to 21 CFR Parts 210, 211 and 600 as applicable. + Initiate new client projects and support providing QA costs (labor, testing, etc.) in collaboration with Program Management teams. + Directs the batch record review and lot disposition activities, including raw materials, to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals + Facilitates QA support and works closely with other Paragon functional units including Manufacturing, Validation, Facilities Engineering and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured. + Serve as team leader in quality investigations and ensure corrective and/or preventative action plans to resolve potential product quality issues are appropriately implemented + Oversees QA Client liaison for hosting routine client audits including coordinating audit support, performing facility tours, answering questions and resolving issues. Ensures response to observations in a timely manner and ensures compliance risks are effectively mitigated + Participate in facility expansion projects, coordinating QA support. The Candidate: + B.S. in a Science or Engineering field + Minimum of 10 years of experience within the life sciences industry, preferably biotechnology or pharmaceuticals with at least 5 of those years in a Quality Assurance role + 5+ years of direct management experience + Thorough knowledge of cGMP regulations, quality systems and regulatory requirements + Proficiency with electronic management systems (such as QDMS, LMS, EDMS, and E-Doc) Key leadership attributes: + Leads with Integrity and Respect + Delivers Results + Demonstrates Business Acumen + Fosters Collaboration and Teamwork + Champions Change + Engages and Inspires + Coaches and Develops Position Benefits + Lead and existing team of QA Associates as well as building out additional teams for fast growing gene therapy products + Gain experience in the cutting-edge gene therapy space + Tuition Reimbursement 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. 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. </script>

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