Position Summary: Catalent Pharma Solutions is Morrisville, NC is hiring a Senior Compliance Specialist for the Quality group. The Quality Assurance department plays a necessary role in the daily operations of the facility. The primary function of the department is to ensure compliance with FDA and other regulatory agency requirements, as well as internal quality systems requirements for the facility. The department is entirely separate from and independent of the personnel engaged in the direction and conduct of the project. This includes project review for accuracy and compliance, systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, and raw material and finished-product release. This is a full-time role position: Monday – Friday, days. 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 Schedule, prepare, and execute post audit activities Manage internal Audit program Idenfiy potential compliance issues, gaps or trends Task corrective measures to prevent compliance issues Support compilation and tracking of metrics related to internal audits Train and qualify personnel on internal audits Ensure compliance with FDA and other regulatory agency requirements Ensure compliance with site specific regulations All other duties as assigned; The Candidate Bachelor’s degree in Chemistry or related physical science from a four-year college/university or equivalent education and job experience 10 or more year’s experience in an FDA regulated industry required 5 or more years of experience required in the pharmaceutical industry with 3 or more years of experience in QA/Regulatory Affairs, preferably in audit functions ASQ CQA, ISO 13485 Lead Auditor, or equivalent, strongly preferred Demonstrated experience with leading or hosting internal/external audits. The employee must have a broad understanding of Quality Management Systems (e.g. Document Control, Deviation Management, Laboratory and Manufacturing Controls) and administrative practices and be able to function independently without close supervision Requires knowledge of ICH Q8, Q9 and Q10 Requires knowledge of US and EU cGMP Regulations (i.e. 21CFR Part 4, 21 CFR Part 11, 21CFR 58, 21CFR 210 and 211). Requires interaction cross-functionally at all levels within the organization Requires excellent written and verbal communication skills 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 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. 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.