Careers

Job Title: Good Manufacturing Practice(GMP) Quality Assurance Manager

Timing: Overlap with PST hours - Upto 2 am IST

Travel: International trips once every quarter expected

Employment Type: Full-time

Workplace Type: Remote

THE CELITO TEAM

The Celito Team architects the buildout of simplified, integrated, and compliant technology stacks. With both consulting and products, our expertise can help our customers save time and money as they move from strategic Clinical & Quality management all the way to widespread and profitable commercialization.

JOB OVERVIEW

We are seeking a highly skilled and experienced Manager/Sr. Manager of GMP Quality Assurance Operations to join our team. This leadership role is responsible for Quality oversight of CMOs manufacturing drug substance, drug product, and packaged product. This role will work closely with the CMC team to ensure compliance across the entire product lifecycle. The role ensures adherence to GMP and regulatory standards while driving continuous improvement. The ideal candidate will possess significant decision-making authority on quality matters and ensure the efficient operation of the QA department.

KEY RESPONSIBLIITIES

GMP QA Operations Responsibilities:

• Perform batch record review and compile documentation packages to support product disposition.
• Conduct technical reviews and approvals of Master Batch Records and executed batch records.
• Review and approve Deviations, CAPAs, Change Controls, and Audit reports.
• Perform technical reviews of Quality Control records, including Certificates of Release, Analytical Protocols, Reports, and Stability reports.
• Support and contribute to the Annual Product Quality Review.
• Author, review, and update QA Operations SOPs and other quality documents.

Quality Oversight and Compliance Responsibilities:

• Ensure Quality and Compliance oversight of CMOs per quality agreements, including periodic site visits as needed.
• Oversee CMO/CSPs through remote collaboration, on-site visits, KPI monitoring, and adherence to quality agreements.
• Conduct vendor/CMO audits.
• Prepare, manage, and execute Quality Agreements.
• Provide Quality oversight and representation on external CDMO project teams; manage CDMO relationships.
• Coordinate and manage compliance activities in preparation for regulatory and internal inspections, and support interactions.

External Audits and Regulatory Inspections:

• Lead preparations for external audits and regulatory inspections.
• Serve as the subject matter expert (SME) and host during audits and inspections.
• Develop and implement strategies to maintain continuous inspection readiness.

Additional Responsibilities:

• Collaborate effectively with functional teams such as CMC, Supply Chain, and Regulatory.
• Escalate critical quality and compliance issues to management in a timely manner.
• Manage critical quality issues with Vendors/CMOs and provide prompt resolutions.
• Identify process gaps proactively and implement mitigation strategies.

QUALIFICATIONS

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Chemistry, Engineering). Advanced degree preferred.
• 13+ years of experience in quality assurance role in the pharmaceutical industry required with at least 5+ years in Quality Operation roles in a current Good Manufacturing Practices (cGMP) environment
• Strong working knowledge of FDA regulations (21CFR, 210/211), ICH guidelines, and global regulations (EU Directives, and ROW) and expertise in the cGMP requirements pertaining to manufacturing and packaging operations (including serialization) in the United States and globally in support of global commercial production activities
• In-depth knowledge of cGMP and strong understanding of the entire product lifecycle.
• Proven experience in conducting GMP audits and inspections is preferred.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a multidisciplinary team.
• Certification in GMP or related areas is preferred.
• Experience working with US and European companies is required.