Senior Quality Specialist (QA/QC)

Location: Singapore Moleac is a biopharmaceutical company focused on addressing unmet medical needs by bringing innovative products to patients worldwide. With a dynamic, fast-paced, and mission-driven environment, Moleac is committed to improving health outcomes and delivering quality through excellence in our global operations. We are seeking a Quality Specialist to own and continuously improve our product quality to our customers, through the implementation and improvement of our Quality Management System (QMS) while maintaining hands-on responsibility for QC review and product release activities. This role combines strategic quality system ownership (QA) with deep involvement in analytical and batch data review (QC).You will act as the key quality interface with CMOs, contract laboratories, and suppliers, ensuring consistent implementation, data integrity, and product quality across the entire supply network. This role also serves as a Quality team player with CMC, Regulatory Affairs (RA), and Supply Chain departments, requiring sound risk-based decision-making to balance compliance, operational efficiency, and business priorities in a fast-paced outsourced environment. This position will also work closely with corporate QA/compliance for advice and support. This is a high-impact role for someone who wants to build, strengthen, and directly influence quality in an outsourced pharmaceutical environment. ESSENTIAL DUTIES & RESPONSIBILITIES 1. Quality System Ownership & Continuous Improvement (CMC QA) · Own and maintain Quality Management System (QMS) for CMC, ensuring it is compliant, effective, and inspection-ready • Ensure quality systems support both compliance and operational efficiency · Drive continuous improvement of quality processes, systems, and documentation · Develop and manage SOPs, specifications, analytical methods, and controlled documents · Establish and enhance quality oversight frameworks for outsourced manufacturing, testing, and distribution · Monitor quality metrics, trends, and system performance to identify risks and implement preventive actions · Perform and/or coordinate quality checks to verify compliance of outsourced manufacturing, testing, and distribution activities with GMP and GDP requirements 2. External Partner Quality Oversight (CMOs, Labs, Suppliers) · Act as the primary quality representative for contract manufacturers, testing laboratories, and material suppliers · Lead or co-lead qualification, onboarding, and periodic performance review of CMOs, labs and suppliers · Maintain and update quality agreements, ensuring clear accountability and compliance expectations · Ensure partners maintain GMP/GDP compliance, appropriate certifications, and inspection readiness · Ensure contract laboratories maintain appropriate accreditation, qualifications, and compliance status · Evaluate partner performance using quality data, audit outcomes, and trend analysis, and drive improvements 2. Batch Release & Quality Review (with Supply Chain) · Review manufacturing batch records and Certificates of Analysis (CoA)from contract manufacturers and testing reports from testing laboratories in a timely manner · Collaborate with Supply Chain to prioritize release activities aligned with business needs · Ensure manufacturing and testing activities comply with approved specifications, validated/approved methods, and regulatory filings · Perform timely QC release for raw materials, packaging materials, intermediates, and finished products · Maintain batch release trackers and ensure completeness of required quality documentation · Identify, assess, and escalate quality risks impacting batch disposition · Support supply continuity by proactively identifying and mitigating quality-related risks 3. Analytical & Stability Program Oversight(with CMC) · Oversee analytical testing activities conducted by external laboratories · Maintain trackers and testing schedules to ensure timely completion of required analyses · Support management of stability programs, including monitoring of stability study schedules and review of stability data · Assist in trending analytical results and identifying potential quality trends or deviations · Review and approve stability study protocols to ensure compliance with GMP, internal procedures, and regulatory expectations 4. Quality Event Management · Track and support investigations related to deviations, Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, and product complaints reported by contract manufacturers or laboratories · Monitor implementation and effectiveness of corrective and preventive actions (CAPA) and ensure timely completion · Maintain logs and trackers for deviations, investigations, and quality events · Assess potential quality impacts to released or in-process batches · Support investigation for customer complaint 5. Change Control & Supplier Quality · Support and assess changes to manufacturing, analytical, or supplier through the company’s change control process · Track implementation of changes affecting manufacturing processes, testing methods, or product specifications, aligned with CMC and regulatory requirements · Maintain oversight of qualification and validation documentation, including process validation and analytical method validation records Qualifications · Diploma or Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biotechnology, or a related discipline · 5-7 years of experience in pharmaceutical, biotech, or GMP-regulated environments · Familiarity with cGMP, pharmaceutical quality systems, and regulatory requirements · Familiarity with GDP requirements for distribution activities is an advantage · Experience working with contract manufacturers in China and Singapore or testing laboratories is advantageous · Strong attention to detail and ability to manage technical documentation · Strong coordination and communication skills for working with external partners and internal stakeh…