Manager, Quality and Compliance

Catalent

Madison,WI  

2019-11-18 2019-12-18
compliance manager quality administration pharma

At Catalent, we recognize talent is our most important asset. Propelled by the passion to excel, we are committed to attracting, developing, and retaining talented and dedicated professionals who can help us deliver on our promise of more products, better treatments, reliably supplied.

From helping our customers produce world-class pharmaceutical products to identifying future technologies that will improve drug delivery, we achieve our amazing breakthroughs and innovations because of our talent!



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 Manager, Quality and Compliance is responsible for assuring the systems and processes required to assure regulatory compliance and patient safety are met. The primary function of the department is to ensure compliance with FDA, EU, and other regulatory agency requirements, as well as internal quality systems requirements for the facility. The quality unit is solely responsible for product disposition, including release and rejection of products at the site. The department is entirely separate from and independent of the personnel engaged in the manufacturing of the cGMP products produced.







The Manager, Quality and Compliance is responsible for providing leadership to ensure the site’s overall compliance with regulatory requirements and Catalent policies and procedures; for oversight and management of Catalent’s audit program including client audits and self-inspection program; for driving continuous improvement projects to ensure regulatory expectations for both clinical and commercial programs are achieved; to support quality improvement initiatives with comprehensive perspective and identifying business process risks; and for developing recommendations and supporting goals to ensure the site is meeting and exceeding client expectations in terms of quality.







In concert with Catalent’s Patient First philosophy, the Manager, Quality and Compliance collaborates with both internal and external partners to enhance and improve the lives of patients. Quality and Compliance is dedicated to delivering results at every level to focus on the needs of patent first.







The Role





+ Maintains licenses and registrations to ensure continuity of site operations; manages the content of facility site master file(s).



+ Prepares and organizes quality documentation for client regulatory submissions, provides regulatory guidance and support for development and production activities.



+ Maintains awareness of changes in global regulatory requirements and industry compliance trends for effective regulatory submissions and production documentation, serves as regulatory liaison with the applicable Health Authorities for assigned projects, provides written documentation of interactions with regulatory agencies, assists Catalent’s global Regulatory Affairs function in the maintenance of facility registrations.



+ Develops and implements regulatory strategies to facilitate compliance and foster client relationships; applies advanced theoretical knowledge and contributes to the development of new principles and concepts.



+ Provides reliable / dependable interpretations of regulatory guidance for clients and is capable of defending these positions to regulatory agencies.



+ Leads regulatory and client audits.​









The Candidate

+ BS in Science or related degree





+ Master’s degree preferred









​Experience:





+ 5 - 10 years of pharmaceutical industry experience, preferably cGMP









Catalent’s standard leadership competencies that are used to interview and for Performance & Development





+ Leads with Integrity and Respect



+ Delivers Results



+ Demonstrates Business Acumen



+ Fosters Collaboration and Teamwork



+ Champions Change



+ Engages and Inspires



+ Coaches and Develops









Position Benefits





+ Fast tracked career growth, with annual performance review and feedback process



+ Competitive base salary with other compensation incentives including yearly incentive plan



+ Medical, Dental, Vision, and 401K are all offered on day one of employment



+ 19 days of Paid Time Off (PTO) + 7 paid holidays



+ Onsite gym, Catalent corporate discount perks, paid volunteer time off program and other benefits too numerous to mention!



+ Defined career path and annual performance review and feedback process













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.





Paragon Gene Therapy, a unit of Catalent Biologics, in Baltimore, Maryland is a leading viral vector development and manufacturing partner in the rapidly expanding gene therapy market. To browse career opportunities in Maryland, click here.





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.
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