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
This role will report directly to the Director, Quality Assurance
Manage controlled substance activities under the direction of the Director of Quality Assurance specific to all regulatory requirements set forth in the U.S. Code of Federal Regulations (CFR). Examples including but not limited to the maintenance of documentation, controlled records, storage requirements, report submission and day to day management of controlled substance activities.
Position must adhere to all site SOP's, federal and state laws, OSHA guidelines and any other regulated authorities specified by the site.
Our Somerset location is the corporate headquarters for Catalent Pharma Solutions. This location houses our state-of-the-art laboratory, clinical, commercial manufacturing plant for oral dose forms in addition to being the Center of Excellence for Highly Potent Active Pharmaceutical Ingredients.
Supervises and coordinates all DEA activities of personnel engaged in the DEA Department as well as enforces and ensures site meets compliance requirements regarding controlled drug handling.
Authors investigations, SOP's, controlled documents and responses when applicable to comply with government, corporate and site requirements.
Manages, supports and facilitates successful DEA, corporate and customer audits at the site.
Manages a training program specific to controlled substances in the areas of new employee training, controlled substance access, designated observer, documentation transactions, and any area identified by site leadership.
Manage/verify controlled substance transactions (receipts/distributions) as well as DEA registrations.
Perform internal DEA audits as well as assess current systems. Recommend and implement improved tracking/reconciliation tools to enhance compliance where applicable.
Bachelor's Degree in related field with a minimum of 5 years within the pharmaceutical industry and at least 3 years of controlled substance experience.
Previous management experience preferred.
Experience working in a high paced environment with multiple competing priorities
Candidate must have a strong understanding of CFR Part 1300 and cGMP compliance.
High level of attention to detail and accuracy. Ability to communicate clearly and concisely (both written and verbal, presentation and interpersonal skills)
Ability to interact and communicate with all levels of organization and cross-functional teams
Leadership Competencies for Performance and Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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 Pharma Solutions, Inc.