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Associate Director, Quality

Job Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

Our Manassas, Virginia site is a part of the Consumer Health division and provides expanded capabilities in soft chews and lozenges. With extensive development and manufacturing expertise and a wide range of flavors, ingredients, and colors available, we can work with complex formulations to help create engaging new products consumers will love.

Reporting to the Vice President Quality, Consumer Health and as a member of the Site Leadership Team the **Associate Director, Quality** is accountable for the direct management and guidance in the Quality and cGMP aspects of the organization. The individual will act as the Leader of Food Safety, Quality and Regulatory activities in the manufacturing site and will be accountable for maintaining the highest standard of Dietary Supplement Manufacturing, Food Safety, Food Quality and Food Security. The **Associate Director, Quality** will ensure regulatory compliance with all applicable Federal, State, and Local regulations and compliance to customer and internal product specifications.

The Job

+ Responsible for ensuring that the necessary systems are in place to support compliance with Dietary Supplement cGMP requirements for the CatalentWellness facility, processes and people for the markets in which its products are sold.

+ Food Safety and Quality Team responsibility: developing, validating, verifying and maintaining Food Safety Plans and Pre-requisite programs.

+ Direct all functional and operational aspects of the Quality Assurance program to ensure compliance with all appropriate regulations and standards.

+ Supervise, provide guidance and leadership to plant Quality organization and development of the same.

+ Lead client, third-party, and FDA quality assurance audits along with senior management.

+ Develop and refine plant measurement techniques, control plan and corrective action activities. Liaise with various departments to modify standard operating procedures, and create new ones as needed.

+ Review and ensure compliance with plant GMP’s, HACCP, sanitation and pest control procedures and standards.

+ Ensure internal compliance assessments of the siteare appropriately managed and that responses to resolve deficiencies are provided and communicated in a timely manner.

+ Execute against company established Key Performance Indicators for Quality in collaboration with Operations.

+ Other duties assigned.

The Candidate

+ Bachelor’s degree in Food Safety, Microbiology, Chemistry, Food Science, Engineering, or other science related field required.

+ Knowledge of the industry's regulatory environment, specifically with 21 CFR 111 and 117 required.

+ 5+ years of progressive Quality experience within the dietary supplement and/or food industry, with at least 3 years in a management leadership position in a manufacturing environment required.

+ Excellent leadership, organizational, and communication skills. Experienced, yet energetic, and innovative with an ability to embrace the entrepreneurship of a startup operation.

+ GFSI, HACCP and PCQI trained; NSF, SQF and UL certification experience preferred.

+ Direct experience in the development and execution of Quality System, Food Safety and Sanitation programs.

+ Demonstrated Investigation, Root Cause Analysis, and Corrective Action capabilities.

+ Direct experience in the mentorship and development of direct and indirect team members.

+ Proficiency in Excel, Word, PowerPoint and other similar computer applications.

+ The employee must be able to lift and/or move up to 50 pounds. While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear. The employee is required to sit, climb or balance and taste or smell.

Why you should join Catalent

+ Diverse, inclusive culture

+ Competitive salary

+ 401(k) retirement savings plan with company match

+ Educational assistance/reimbursement

+ 152 hours of paid time off + 8 paid holidays

+ Medical, dental, and vision insurance

+ Life insurance

+ Wellness programs

+ Flexible spending account

+ Employee discount programs

+ Robust employee referral program

**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 Catalent Careers (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .