Group Leader - Quality Management Systems

Position Summary:
Catalent Pharma Solutions is Morrisville, NC is hiring a Group Leader for the Document Control and Regulatory team. The primary function of the department is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality system requirements for the facility. This person will manage a compliance/regulatory team responsible for compliance activities at the site. This person will also manage/lead audits of the Morrisville site to ensure compliance with cGMPs, and standard operating procedures.
This is a full-time position: Monday - Friday, 8:00AM - 5:00PM.
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 Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.
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

• Manage a team responsible for Compliance activities at the site, including monitoring and managing Documentum, Document Control Unit, and the Quality Specialist-Metrics.
• Contribute to process improvement initiatives related to Documentum, DCU, Audits; and ensure that organizations' requirements are met in the most cost and resource efficient manner, creating room for expansion, growth, and profit
• Manage/lead audits of the Morrisville site to assure compliance with EU and FDA cGMPs, Corporate, and Pharmaceutical Development standard operating procedures policies. Ensure that customer's requirements are met. This includes Regulatory and Customer audits of the facility as required. Participate in activities in preparing the site for inspections by US and foreign regulatory authorities and corporate auditors and participate in these inspections
• Liaise with internal and external customers as required for all aspects of Quality Agreements and Regulatory Submissions. Maintain responsibility for interpretation and implementation of cGMPs and other FDA regulations and pronouncements
• Support site in compliance and regulatory matters as required. Act as primary contact with customer for compliance matters
• Approve department procedures and assist in the development of new procedures and/or revision of existing procedures
• Provide department quality metrics and tracker information to Senior Management monthly
• Apply for and manage state licensures for the site
• All other duties as assigned;

The Candidate

• Bachelors degree in Chemistry, Microbiology, Pharmacy, or a related science is required
• 1 or more years of experience in compliance, auditing, data review is required
• Experience working with agencies in a regulatory capacity is required
• Experience working in Quality Assurance or Quality Control with progressive management responsibilities is strongly preferred
• Full understanding of FDA and EU cGMPs and DEA regulations pertaining to clinical trial and commercial manufacturing is preferred
• Strong written and verbal communication skills required
• Good understanding of statistics and audit techniques is required
• Must be well-organized with the ability to multitask
• Experience in a supervisory or management role is strongly preferred
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 152 hours of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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 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.
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 spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.