Manager, QA (Audit)
Overview
People are at the center of who we are and what we do.
Are you seeking…
– A culture defined with the help of your voice?
– Recognition for your talent and continued growth opportunity?
– Upfront tuition assistance (eligible day one of employment)?
– A dynamic benefits package (eligible day one of employment)?
– A place where what you do impacts lives?
The Quality Assurance (QA) Manager's primary role is to maintain appropriate oversight of cGMP processes to ensure the quality of produced pharmaceutical and medical device products.
Requirements:
Responsibilities
– Managing and monitoring quality assurance site audit functions working with Catalent Corporate Quality (i.e., internal and customer audits)
– Provide support and participate in regulatory agency inspections (US FDA, ROW)
– Providing oversight for processes to ensure regulatory compliance to FDA regulations, global regulations and Catalent internal directives in the manufacture of pharmaceutical products and medical devices
– Establish, track and present Quality Metrics to support Quality Management Review
– Managing staff of 3-10+
– Providing direction on daily work and setting objectives and plans for activities for up to 1 year in advance
Qualifications
– Bachelor's degree preferred
– 3-5 years of leadership experience
– Previous experience participating in regulatory agency inspections
Core Competencies
Decision Quality
Ensures Accountability
Collaborates
Manages Ambiguity
About Catalent
Cook Pharmica in Bloomington, Indiana, now part of Catalent, is committed to excellence in Indiana's growing life sciences industry. We know that hiring best-in-class people will support our ultimate mission, which is to partner with our customers to deliver life-enhancing biopharmaceutical discoveries to patients worldwide. We take great pride in our award-winning facility and boast a work environment that provides excellent earnings opportunities and benefits, attractive and progressive employment programs, and a place to make a career for both junior and experienced talent who wish to do important and innovative work that makes a positive impact on the world.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help develop some of the nearly 200 products we launch each year or help supply over 7,000 products for patients around the world. Catalent is an exciting and growing international company where our professionals 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, for the benefit of patients globally.
Catalent. More products. Better treatments. Reliably supplied. ™
Catalent takes great pride in offering employees a benefits package that includes:
– Diverse, inclusive culture
– Competitive salary with quarterly bonus potential
– 401(k) retirement savings plan with company match
– Educational assistance/reimbursement
– Paid time off
– Medical, dental, and vision insurance
– Life insurance
– Flexible spending account
– On-site fitness center and wellness programs
– Excellent on-site cafeteria
– Employee discount programs
– Robust Employee Referral Program
“Qualified candidates must be legally authorized to be employed in the United States. Catalent does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.”
“We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.”
Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state, and local law.
