Job Description

Job Responsibilities:

• Lead the development, implementation, and upkeep of the site's quality management systems and associated procedures.
• Review and authorize documents related to changes in processes or products, including Change Control and Process Management.
• Serve as a key point of contact for regulatory bodies like the FDA during on-site audits.
• Approve and assess validation documents, requirement specifications, SOPs, and data integrity evaluations.
• Gather, evaluate, and report on quality system data to ensure compliance, track trends, and identify areas for improvement.
• Conduct audits of quality systems and propose corrective actions based on findings.
• Develop and refine procedures, conduct statistical evaluations, and address system remediation needs.
• Thrive in a fast-paced and dynamic environment with a flexible mindset.
• Foster effective communication and positive relationships with diverse internal and external stakeholders.
• Promote a safe, compliant working environment through training, awareness, and adherence to safety guidelines and SOPs.
• Oversee the upkeep of department facilities and equipment.
• May involve additional responsibilities such as developing specifications, SOPs, providing quality system training, and participating in Quality Review Board meetings.
• Ensure compliance with US and international regulatory standards (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
• Devise creative solutions to complex problems in alignment with organizational goals.
• Advise management on ways to enhance operational practices and technologies.

Qualifications:

• A Bachelor's degree in Biology, Chemistry, Life Sciences, or a related field is required.
• At least 8 years of relevant experience in Quality or Validation within a pharmaceutical manufacturing environment, with extensive knowledge of quality systems.
• Proven experience in supporting inspections conducted by regulatory authorities.
• Solid background in investigating deviations and variances.
• In-depth knowledge of regulatory guidelines for establishing, validating, and documenting test procedures, equipment, processes, and facility systems.
• Familiarity with cGMP guidelines and their implementation in aseptic environments.
• Ability to collaborate effectively with cross-functional teams to resolve issues and ensure compliant outcomes.
• Proficiency in statistical tools and Microsoft Office suite.

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