Position Summary:

Catalent Pharma Solutions is hiring a Regulatory Compliance Specialist to join the Regulatory Compliance/Quality Systems branch of the Quality Assurance organization at the Morrisville RTP location. The Quality Assurance Audits group will serve as Audit/Inspection Readiness specialists that will be responsible for oversight of the external (customer/supplier) and internal audit programs, supporting regulatory inspections, and serve as the site’s audit experts to ensure site readiness for regulatory inspections. The Regulatory Compliance Specialist would be responsible for overseeing execution and administration of the Customer Audit Program.

This position requires independent judgment to resolve issues and design systems / solutions. Independently able to create process maps and develop / drive / implement improvement of critical Quality Systems and ensure compliance with ICH Q10. Able to use risk management tools in the design of solutions. Act as a resource for internal and external customers regarding Quality Systems issues. Ability to lead and manage customer audits as well as internal systems audits and external supplier audits. Position requires a good degree of initiative and independent judgment to resolve problems and create solutions. The work is complex and may or may not be covered by adequate procedures.

This is an onsite full-time position

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

• Hosts and/or supports customer audits; ensures appropriate and sustainable action plans are developed and implemented.

• Supports the resolution of issues relating to quality.

• Assist with mock regulatory inspections and regulatory facility inspections by acting as scribe and/or reviewing documents; identifying and contacting operational staff to answer questions as needed.

• Ensure proper conduct of customer-initiated audits and mock regulatory inspections.

• Ability to develop/write audit responses.

• Development and implementation of administrative SOPs.

The Candidate

• Requires Bachelors of Science in a Life Science or other scientific/technical related discipline with a minimum 2 years of experience in a pharmaceutical, biotech, or other regulated area, of which 3 years are in Quality Assurance, or relative experience.

• Requires experience interfacing with external and internal customers.

• Requires result oriented, self-motivated, self-starter with flexibility to adapt to changing priorities, ability to manage multiple projects/activities simultaneously, and to deliver on aggressive project timelines.

• Requires working knowledge of good documentation practices and FDA/GMP regulatory requirements and guidance documents specifically including data integrity and Part 11/Annex 11.

• Practical experience in conducting audits (internal and/or external).

• Prefers strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants and contractors.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

• 19 days of PTO + 8 paid holidays

• Several Employee Resource Groups focusing on D&I

• Dynamic, fast-paced work environment

• Employee Stock Purchase Program

• 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.