Job SummaryThe Senior Director of Quality Control is the highest authority for the release of finished products and holds full accountability for ensuring that all products comply with regulatory requirements and company quality standards. This individual provides strategic leadership for the Quality Control (QC) function and leads initiatives to improve GMP, GDP, and GLP compliance, enhance production quality, and develop a strong quality culture. The Senior Director plays a critical role in supporting business continuity, regulatory readiness, and long-term operational excellence.
Job Description - - Serve as the final decision-maker for product release, ensuring compliance with all internal quality standards and applicable regulatory requirements (e.g., FDA cGMP).
- - Lead the development and continuous improvement of Quality Systems, including GMP, GDP, and GLP programs.
- - Direct and oversee quality improvement projects across production lines, including defect rate reduction initiatives and quality award systems.
- - Build, lead, and mentor a high-performing Quality Control organization, fostering accountability, technical expertise, and leadership development.
- - Approve and oversee preparation of GMP-related documents, protocols, and standard operating procedures.
- - Serve as a subject matter expert and primary escalation point for quality-related issues across the manufacturing environment.
- - Optimize departmental performance by implementing KPIs, evaluating resource needs, and streamlining QC workflows.
- - Ensure full implementation and compliance with all departmental functions and daily operations per applicable regulatory standards (e.g., FDA, ISO, GMP, GLP, industry-specific regulations).
- - Collaborate cross-functionally with manufacturing, regulatory affairs, R&D, and corporate headquarters to maintain audit readiness and product quality.
- - Manage departmental budgets and oversee expenditures in alignment with corporate financial targets.
- - Develop and implement staff training programs to enhance technical capabilities and compliance awareness.
- - Participate in executive-level strategy and planning meetings and represent the QC function in corporate quality initiatives.
- - Lead investigations into customer complaints and non-conformities, identifying root causes and executing corrective and preventive measures.
- - Lead and manage internal, customer, and third-party audits.
Qualifications - - Bachelor's degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) required; Master's or higher preferred.
- - 10?15 years of progressive experience in Quality Control or Quality Assurance in a GMP-regulated industry (e.g., cosmetics, pharmaceutical, biotechnology, or medical devices).
- - Proven leadership experience in directing multi-disciplinary quality teams.
- - Expert knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and related quality regulations.
- - Strong decision-making skills and ability to independently resolve complex quality and compliance issues.
- - Excellent communication, collaboration, and organizational skills.
- - Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) and familiarity with quality management systems (QMS) or laboratory information systems (LIMS).
What's On Offer Comprehensive health insurance, 401K, PTO, other company's benefit and perks
Apply online or feel free to contact us directly for more information about the opportunity. Due to the high volume of applicant, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.
