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Director of Quality Assurance
2 months ago
Job Title: Director of Quality Assurance
Job Summary:
Abinitio Pharma is seeking a strategic and experienced Director of Quality Assurance to lead our quality and compliance agenda within our GMP facility.
Key Responsibilities:
- Strategic Leadership: Set the strategic direction for quality and compliance, overseeing all related functions to align with clinical trial requirements and regulatory standards.
- GMP Compliance: Guide the business in maintaining a GMP-compliant facility licensed through regulatory authorities, maintaining the electronic Quality Management System (e QMS), approving documentation, and training staff on GMP practices specific to clinical trial production.
- Quality Assurance: Establish and maintain robust quality assurance protocols that encompass the entire lifecycle of clinical trial products—from development to production, ensuring that all processes meet regulatory and company standards.
- Risk Management: Strengthen internal capabilities to achieve project outcomes while effectively managing operational quality controls and risks associated with clinical trial products.
- QC Oversight: Oversee the Quality Control (QC) function, ensuring timely completion of tasks, including effective investigations of out-of-specification (OOS) results and implementing corrective and preventive actions as necessary.
- Cross-Functional Collaboration: Collaborate with clinical, development, and production teams to ensure seamless integration of quality assurance practices into production processes, emphasizing adherence to protocols and timelines.
- Regulatory Expertise: Act as a key point of contact for regulatory inspections and audits, demonstrating a deep understanding of quality assurance principles and compliance regulations related to clinical trials.
- Authorised Person Responsibilities: Serve as the Authorised Person, fulfilling all GMP responsibilities, ensuring that all standards are met before the release of clinical trial products.
Key Attributes:
- Detail-Oriented: A meticulous approach to quality assurance, with a keen eye for details that can impact product safety and efficacy.
- Analytical Thinker: Strong analytical and problem-solving skills to navigate complex quality issues and implement effective solutions in a fast-paced environment.
- Effective Communicator: Excellent communication skills to convey quality standards and protocols to all levels of the organization, fostering a culture of quality and compliance.
- Leadership Skills: Proven leadership capabilities to inspire and guide teams in upholding the highest standards of quality in clinical trial product production.
