Laguna | On-site | Monday to Friday
Sr. Manager | Director | AVP | SVP | Head
About The Role
We are seeking a highly experienced
Head of Quality Assurance (QA) to lead and oversee all quality systems within our pharmaceutical manufacturing operations. This executive role is critical in ensuring full compliance with regulatory standards and maintaining the highest level of product quality, safety, and efficacy.
Key Responsibilities
- Develop and implement the overall Quality Assurance strategy and quality management systems
- Ensure compliance with global regulatory standards (e.g., GMP, FDA, EMA, ASEAN guidelines)
- Oversee batch release, validation, qualification, and documentation processes
- Lead internal and external audits, regulatory inspections, and compliance initiatives
- Establish and maintain robust CAPA (Corrective and Preventive Actions) systems
- Collaborate with manufacturing, R&D, regulatory, and supply chain teams
- Manage risk assessment and quality improvement initiatives
- Ensure proper training and development of QA personnel
- Act as the primary point of contact for regulatory authorities and quality-related matters
Qualifications & Requirements
- Minimum 10 years of experience in Quality Assurance within pharmaceutical companies or pharma-related industries
- Strong expertise in GMP compliance, quality systems, and regulatory requirements
- Proven leadership experience in senior QA roles (Director, AVP, SVP, or equivalent)
- Experience handling regulatory audits and inspections
- Strong knowledge of validation, documentation, and quality risk management
- Bachelor's degree in Pharmacy, Chemistry, or related field (advanced degree preferred)
- Excellent leadership, analytical, and problem-solving skills
