Computer System Validation Manager Jobs in Clementon, NJ

Director, Quality

Position Summary:

• 100% on-site

Catalent's 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation.

The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent complies with all applicable regulations and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and Australian agencies and other international and/or local health authorities.

The Director of Quality is responsible for providing leadership and Quality Management support within each of the Clinical Specialty Services divisions. This individual will have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, and Customer relations.

The Role:

• Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance.

• Management responsibilities include professional development, performance appraisals, and employee counselling for direct reports. Assigns work and reviews workload for all direct reports. Supervises staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level.

• Recommends courses of action on all management/human resources' matters, including salary administration, transfers, hiring, terminations, and position description preparation.

• Promotes, implements, and maintains quality initiatives of processes and programs to assess compliance with regulations, Global and Site SOPs, and client requirements.

• Provides to the Operational CDS and Quality organization consultation, and interpretation of regulations/guidelines related to GXPs focused mainly on good clinical trials, as applicable.

• Writes and approves Quality unit SOPs and Forms, as needed. Approves Operational CDS SOPs and Forms. Supports harmonization of worldwide Quality operating procedures as needed.

• Provides leadership for Data Integrity and Computer System Validation documentation review and approval for instruments, equipment, and systems used in GXP Operations throughout the system life cycle.

• Assist with Client Audit and Regulatory Agency inspections.

• Provides direction in identification and implementation of quality improvement programs.

• Provides leadership for the investigation, root cause analysis, and CAPAs association with Deviations, Non-conformances, Complaints, Client Audits, and Internal Audit Reports.

• Other duties as assigned

The Candidate:

• BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience.

• 10 + years of Scientific or Pharmaceutical Quality Assurance, preferring clinical supply services, in addition to commercial packaging.

• Clear understanding of cGMPs including clinical trials.

• Communicates clearly with internal and external clients, both verbal and written.

• Cooperates with co-workers; is a team player. Willingness to contribute to team activities.

• Demonstrates flexibility in organizing work and priorities.

• Good organizational skills relating to management of associates' daily activities.

• Good problem-solving skills and decision-making skills to identify and solve work related issues.

• Good change management skills and strategic thinking

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Why you should Join Catalent:

• Defined career path and annual performance review and feedback process

• Diverse, inclusive culture

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

• Dynamic, fast-paced work environment

• Community engagement and green initiatives

• Generous 401K match and Paid Time Off accrual

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

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 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.