Quality Assurance Manager
Quality Assurance Manager
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Salary Not Disclosed
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Job Description
Quality Assurance Manager
Position 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 lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality 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 lifeenhancing and lifesaving treatments for patients annually.
This 206878 squarefoot facility located in the Philadelphia area is Catalents global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along with semiautomated and automated wallet sealing and highspeed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs. Using our Clinicopia global labeling system with its multilingual label phrase library we can design single panel booklet labels or our unique PeelID safe storage labels for your studies. Single panel and PeelID safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.
Catalent Pharma Solutions in Philadelphia PA is hiring a Quality Assurance Manager. The Manager is responsible for coordinating and implementing activities to attain strategic objectives within a single functional area or department and looks to his or her direct supervisor or other peers within the industry for guidance.
This is a fulltime salaried role onsite.
Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.
The Role:
- Write revise and/or review SOPs for approval
- Assist in preparing the site for inspection by regulatory authorities and participating in regulatory inspections as required
- Assign project deliverables to team members with appropriate due dates for project completion
- Provide team members with leadership guidance mentoring coaching and feedback against performance and development objectives
- Review and approve quality records in TrackWise
- Conduct performance reviews recommend salary increases and career planning for all direct reports
- Represent quality department on project teams management teams and other internal forums
- All other duties as assigned
The Candidate:
- Bachelor of Science Degree is required
- At least ten years of experience working in Quality areas in the Pharmaceutical/medical device industry with management responsibilities is preferred
- Experienced working in a cGMP management role with an understanding of compliance and associated regulations is preferred
- Good computer skills including indepth knowledge of MS Office Electronic Document Management Systems (EDMS) TrackWise and ComplianceWire preferred
- Indepth knowledge of Quality Assurance and Regulatory Affairs as applicable to the Pharmaceutical industry
- Required Leadership skills include excellent interpersonal and communication skills with crossfunctional teams the strong ability to lead mentor train motivatedirectand empower ateam influence and lead change and contribute strategic analytical insight for problem solving and work with the team to identify gaps and develop continuous improvement suggestions/ideas
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalentsponsored leadership programs such as NGGL GOLD LEAD Now GM Excellence and GROW) may be considered in place of external experience
- Individual may be required to sit stand walk regularly and occasionally lift 015 pounds
Why You Should Join Catalent:
- Defined career path and annual performance review and feedback process
- Diverse inclusive culture
- 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
- 152 hours of PTO 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic fastpaced work environment
- Community engagement and green initiatives
- Generous 401K match
- Company match on donations to organizations
- Medical dental and vision benefits effective day one of employment
- Tuition Reimbursement Let us help you finish your degree or start a new degree!
- WellHub 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 7000 lifesaving and lifeenhancing 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 . 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.
Required Experience:
Manager
Employment Type
Full-Time
