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Quality Systems

2 months ago

Manassas, Virginia, United States Catalent Pharma Solutions Full time

Position Summary

Quality Systems & Regulatory Manager

The Quality Systems & Regulatory Manager is responsible for the creation and maintenance of the Quality System documentation. He/she will assist the Quality Assurance team with special projects as required and communicate any deviations to management. He/she will comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.

Shift: 1st shift M-F 8AM-5PM

Location: Manassas, VA 100% on site

Catalent's Manassas facility provides expanded capabilities in soft chews and lozenges. The site has the capability to manufacture cold-processed soft chews for nutritional supplements and nutraceuticals, as well as small batch 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.

The Role:


• Plant Subject Matter Expert (SME) for SQF, FSMA/HACCP and 21 CFR 111 Standards and implementation; SQF Practitioner and FSMA PCQI lead for the plant site.


• Responsible for validation of the Food Safety Preventative Controls.


• Manage and report on the Environmental Monitoring program execution, performance and corrective actions; Manage, trend and report Customer Complaints and lead investigations for completion of Customer CARs; Responsible for completion and response to all Customer related Non-conformance reports.


• Support the creation and maintenance of all documentation related to the Quality System utilizing technical writing skills to ensure proper formatting, numbering and organization of all related documents: MMRs, specifications, BPRs, Food Safety and Quality Plans and any other documents as required; Manage the internal plant routing and approval process for new documents and process deviations.


• Lead the internal audit program by managing the internal audit schedule, training of internal auditors, performing internal audits and inspections and documenting all areas of non-conformance to support continuous improvement efforts and ensure corrective actions are implemented to eliminate them.


• Work with Production and Packaging Managers, Supervisors, and R&D to maintain and update records and documentation


• Responsible for ensuring compliance to FDA and cGMP standards through the training and education of the organization; Responsible for supporting Deviation and Change Control program at the plat level.


• Participate in all necessary training as required to successfully perform job responsibilities.


• Other duties as assigned.

The Candidate:


• Bachelor's degree required; preferred major in Food Science or related.


• SQF Practitioner with implementation experience required.


• FSMA Preventative Control and Qualified Individual (PCQI) and HACCP trained within the last 3 to 5 years with experience implementing and validating Food Safety programs.


• Preferred experience: implementing cGMP and 21 CFR 111 Standards, knowledge of NLEA labeling requirements and implementing and managing Environmental Monitoring Programs.


• Ability to communicate with all line level positions and management; Self-starter and must be able to work independently with minimum supervision


• Ability to develop cross functional and multinational relationships to support interaction with various internal customers.


• Knowledge of spoken Spanish is a plus


• Work environment: while performing the duties of this job, the employee is regularly exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate to loud. The position requires working in a humid and warm environment. 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. The position requires a great deal of walking and standing, approximately 85%.

Why you should join Catalent:


• Defined career path and annual performance review and feedback process


• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives


• Dynamic, fast-paced work environment


• Generous 401K match and Paid Time Off accrual


• Medical, dental and vision benefits effective day one of employment


• Generous PTO + paid holidays


• Tuition Reimbursement


• 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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE ) .