QA Ops Manager jobs in United States
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Jubilant Pharma Limited · 2 weeks ago

QA Ops Manager

Jubilant Pharma Limited is a well-established member of the pharmaceutical and biopharmaceutical industries, recognized for its contract manufacturing of sterile injectable vials and allergenic extracts. The QA Ops Manager will oversee Quality Assurance activities during weekday nights, ensuring compliance with regulations and leading quality investigations while collaborating with cross-functional teams.

Health CareManufacturingPharmaceutical

Responsibilities

Provide on-site QA oversight for drug product manufacturing, packaging, and labeling operations during weekday nights (B shift) operations
Perform real-time batch record review and approval to support timely product release
Lead or support investigations into deviations, non-conformances, and quality events occurring during weekday night operations
Ensure compliance with cGMP, internal procedures, and regulatory requirements
Serve as the QA decision-maker for B shift operations, escalating issues as appropriate
Collaborate with cross-functional teams including Manufacturing, Quality Control, and Engineering to resolve quality issues
Support change control, CAPA, and risk assessments as needed
Participate in internal and external audits and inspections, providing documentation and responses as required
Maintain and promote a culture of quality and continuous improvement across weekday night operations
Provide training and mentorship to QA associates and other staff working weekday nights
Ensure the issuance of batch production records and printed packaging components as required by manufacturing processes
When required, establish objectives and conduct performance reviews with direct report personnel
Submit justifications for capital budget items as needed and ensure the approved items are ordered, received and implemented in a timely manner

Qualification

GMP knowledgeQuality AssuranceFDA regulationsPharmaceutical experienceSupervisory experienceTrainingContinuous improvementCross-functional collaborationMentorship

Required

Bachelor of Arts or Science required. 10 years of experience in lieu of a degree required
Minimum 5-10 years' experience required
Supervisory experience required
This position requires knowledge and interpretation of GMP's and quality systems
Ability to identify deficiencies and support identified solutions required

Preferred

FDA regulated industry and Pharmaceutical experience desired

Benefits

Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
Life, AD&D, Short and Long Term Disability
401(k) with company match
Generous paid time off plan
Employee Assistance Program

Company

Jubilant Pharma Limited

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Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to our customers across geographies.

Funding

Current Stage
Late Stage
Total Funding
$400M
Key Investors
Standard Chartered Bank
2022-07-13Debt Financing· $400M

Leadership Team

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Arun Duggal
Jubilant Pharma
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Company data provided by crunchbase