Job Title: Quality Assurance Leadership Role
A seasoned Director of Quality Assurance is required to lead and oversee two critical functions within the Quality Assurance (QA) organization: the Batch Release Team and the Investigations & Corrective and Preventive Actions (CAPA) Team.
The Role: Provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams, aligning with corporate objectives and global regulatory standards. Manage the team's activities and develop strong decision makers and mentors, fostering a culture of accountability, collaboration, and quality excellence.
Responsibilities:
* Direct quality oversight of product release processes, change control, CAPA, deviation management, and risk assessments.
* Oversee the implementation and maintenance of the Quality Management System (QMS), serve as a senior Quality Approver.
* Lead inspections and audits by regulatory authorities and ensure audit readiness at all times.
* Manage self-inspection programs to proactively drive continuous improvement initiatives in QA systems and processes.
* Ensure robust documentation control, including management of batch records, standard operating procedures (SOPs), and quality manuals.
* Collaborate cross-functionally with Manufacturing, Quality Control, R&D, Regulatory Affairs, Supply Chain, and Global verticals to ensure cohesive quality operations.
* Monitor, analyze, and report quality metrics and key performance indicators (KPIs) to senior leadership, driving data-informed decision-making.
* Lead, mentor, and develop the Quality Assurance (QA) team to support a high-performance and continuous improvement culture.
Requirements:
* Bachelor of Science (Pharmacy, Chemistry, Microbiology or related field)
* Advanced degree (M.S., Ph.D., MBA) preferred
* Strong understanding of Annex I, US, and EMA GMP regulations, with practical experience in regulatory audits
* Aseptic manufacturing expertise, proven experience in contamination control strategies
* Minimum 10 years of experience in the pharmaceutical industry with a strong understanding of sterile drug manufacture and cGMP requirements
* Demonstrated ability to manage multiple strategic and operational priorities in a fast-paced environment
* Strong problem-solving and critical thinking skills
* Excellent communication, writing, presentation, and data organisation skills
* Demonstrated interpersonal and leadership qualities
Key Skills:
* Director of Quality Assurance
* Quality Assurance Director
* Head of Quality Assurance