Job Title:
Quality Assurance Director
Overview:
Our client is seeking a seasoned Director of Quality Assurance to lead and oversee two critical functions within the Quality Assurance organization. This role will provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams, aligning with corporate objectives and global regulatory standards.
Key Responsibilities:
* Provide strategic and operational leadership to the Batch Release and Investigations/CAPA teams.
* Manage team activities and develop strong decision makers.
* 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).
* Lead inspections and audits by regulatory authorities.
* Manage self-inspection programs to drive continuous improvement initiatives.
* Ensure robust documentation control.
* Collaborate cross-functionally with Manufacturing, Quality Control, R&D, Regulatory Affairs, and Supply Chain.
* Monitor, analyze, and report quality metrics and key performance indicators (KPIs).
Requirements:
* Bachelor's degree in a relevant field, such as pharmacy, chemistry, or microbiology.
* Regulatory knowledge and experience in Annex I, US, and EMA GMP regulations.
* Aseptic manufacturing expertise and proven experience in contamination control strategies.
* Minimum 10 years of experience in the pharmaceutical industry.
* Demonstrated ability to manage multiple priorities in a fast-paced environment.
* Strong problem-solving and critical thinking skills.
* Excellent communication, writing, and presentation skills.
* Demonstrated interpersonal and leadership qualities.
For further information, please contact us today.