About the Role:The Pharmaceutical QA Director plays a critical leadership role in ensuring the highest standards of quality and compliance within pharmaceutical manufacturing operations. This position is responsible for overseeing all quality assurance activities, including departmental leadership, quality control, and process validation, to guarantee that products meet regulatory requirements and internal standards. The director will lead cross-functional teams to implement and maintain robust quality systems that support drug research projects and manufacturing processes. They will also serve as a key liaison with regulatory agencies, ensuring timely and successful audits and inspections. Ultimately, this role drives continuous improvement initiatives to enhance product quality, patient safety, and operational efficiency across the organization.
Minimum Qualifications:- Bachelor's degree in Pharmacy, Chemistry, Microbiology, or a related scientific discipline.
- Minimum of 10 years of experience in pharmaceutical quality assurance, including at least 5 years in a leadership role.
- Demonstrated expertise in departmental leadership, quality control, microbiology quality assurance, and process quality assurance within a pharmaceutical manufacturing environment.
- Strong knowledge of FDA regulations, cGMP guidelines, and other relevant regulatory requirements.
- Proven experience managing drug research project quality and successfully leading regulatory inspections.
Preferred Qualifications:- Advanced degree (Master's or PhD) in a relevant scientific field.
- Certification in Quality Assurance (e.g., ASQ Certified Quality Auditor or Quality Manager).
- Experience with global regulatory agencies such as EMA, PMDA, or Health Canada.
- Familiarity with electronic quality management systems (eQMS) and data integrity principles.
- Track record of implementing Lean or Six Sigma methodologies in quality assurance processes.
Responsibilities:- Lead and manage the Quality Assurance department, providing strategic direction and fostering a culture of quality and compliance.
- Oversee quality control and quality assurance processes, including microbiology and process quality assurance activities, to ensure adherence to cGMP and other regulatory standards.
- Manage and support drug research project quality requirements, ensuring that all phases of development comply with internal and external quality standards.
- Coordinate and prepare for regulatory inspections and audits, addressing any findings with effective corrective and preventive actions.
- Collaborate with manufacturing, research, and regulatory teams to develop and implement quality systems, policies, and procedures that support continuous improvement.
Skills:The required skills are integral to the daily responsibilities of the Pharmaceutical QA Director. Departmental leadership skills enable the director to effectively manage and inspire quality teams, ensuring alignment with organizational goals. Drug research project management skills are essential for overseeing quality aspects throughout the drug development lifecycle, ensuring compliance and risk mitigation. Quality control and microbiology quality assurance skills are applied to monitor and validate manufacturing processes, guaranteeing product safety and efficacy. Process quality assurance expertise supports the continuous evaluation and improvement of production workflows, while preferred skills such as regulatory knowledge and quality certifications enhance the director's ability to navigate complex compliance landscapes and drive operational excellence.
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