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Lupin Pharmaceuticals · 4 hours ago

Manager, QA Compliance & Audits (MQACA)

Somerset, NJ

Full-time

Hybrid

Mid, Senior Level

$100K/yr - $130K/yr

5+ years exp

Lupin Pharmaceuticals is a fast-growing and innovative company focused on generic and branded pharmaceuticals. The Manager QA, Audits and Compliance is responsible for establishing a robust vendor qualification program and conducting internal and external audits to ensure compliance with FDA regulations and industry standards.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

Responsibilities

Establish and implement policies and procedures about Vendor Qualification Program at Lupin Somerset

Conduct Internal and External audits to identify non-compliances and identify potential risks to materials/products and services as a result of observed non-compliances

Prepare and issue audit reports to communicate risks / non-compliances to respective department heads or vendors; collaborate with them for prompt resolution of identified issues

Support onsite and remote customer / regulatory audits. Assist with completing customer / regulatory commitments through the implementation of appropriate CAPAs

Propose, review, and/or implement appropriate corrective actions and preventive actions (CAPA) based on the observations

Liaise with floor management and SMEs to identify additional procedural controls for overall improvement of compliance

Perform Risk Analysis for the products/materials in collaboration with SMEs. Escalate risks/issues to site leadership where necessary

Verify the CAPA effectiveness periodically and modify the CAPA accordingly

Other duties as assigned by leadership

Qualification

Quality AssuranceFDA regulationsInternal/External AuditingElectronic Quality Management SystemASQ-CQA certificationAnalytical skillsCoordination skillsInfluential skillsMS Office applicationsVerbal communicationWritten communication

Required

Minimum Bachelor's Degree in a scientific or technical field; graduate degree desired

5+ years' of extensive experience in the pharmaceutical industry in Quality Assurance. Cross-functional experience in Manufacturing, Packaging, Engineering, Technical Operations, Laboratory or Product development is a plus

Working knowledge of FDA and applicable non-US regulations, guidance and industry standards about pharmaceutical drug manufacturing and auditing

Experience with internal/external auditing and hosting customer / regulatory audits is required. ASQ-CQA certification desired

Excellent verbal and written communication skills

Experience in using electronic Quality Management System, ERP system, MS Office applications

Excellent analytical, coordination and influential skills; Must be able to persuade vendors and cross-functional teams to achieve resolution of issues

Benefits

Discretionary performance bonus

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)