Quality Assurance Manager

Key Responsibilities:

• Administer and maintain the electronic Quality Management System (eQMS) for document control, training, CAPAs, deviations, and change control
• Collaborate cross-functionally with departments including CMC, PV, R&D, and Regulatory Affairs
• Work closely with other departments to facilitate actions and maintain compliance with the current systems for change controls, CAPA, deviations, complaints, internal GxP audit observation follow up
• Serve as liaison with CDMOs, and internal CMC team to ensure timely execution of projects and quality deliverables, including review of batch records, validation protocols, reports, analytical methods, COAs, and quality agreements.
• Coordinate and support internal and external audits, including FDA inspections.
• Manage and track CAPAs, deviations, and non-conformances to ensure timely investigation and resolution
• Aid with development of CAPA plans and implement these within a given timescale to eliminate the root cause of a non-conformance
• Maintain training records and ensure staff are trained on current SOPs and policies
• Assist in the development, review, and approval of SOPs, work instructions, and quality-related documentation
• Update, maintain and improve quality management system process documents
• Develop, update and maintain workflows
• Educate the team on quality related procedures as needed
• Perform data analyses, prepare quality trend/metrics, and report results to interested internal parties
• Participate in the qualification, monitoring, and auditing of vendors and contract manufacturing/analytical organizations
• Carrying out investigation of GxP non-compliances and/or customer product quality complaints
• Support product release and quality review processes, including batch record reviews as needed
• Utilize quality tools and techniques to perform and document full root cause investigations, to evaluate and resolve quality issues, and to enhance continuous improvement
• Creation and control of product specifications
• Carrying out PQRs (product quality reviews) as required
• Keep abreast of changes in regulations and industry trends to ensure the company remains compliant and competitive

Key Requirements:

• BS/BA required preferably in a health-related, life science area or technology-related fields
• 5-10 years of experience in Quality Assurance within the pharmaceutical, biotech, or related regulated industry
• Proficient in English language (spoken and written)
• Solid understanding of GxP, cGMPs, FDA regulations (21 CFR Parts 210/211), and ICH guidelines
• Experience with eQMS platforms
• Experience in utilizing quality System processes (such as, Audit, Deviations, CAPA, Change Control)
• Strong attention to detail, organizational, and time management skills
• Excellent verbal, written, administrative and people skills
• Ability to clearly and concisely communicate technical information
• Ability to work effectively in a fast-paced, collaborative, and dynamic small-company environment
• Relevant experience in a pharmaceutical or other life science organization
• Good experience of articulating and implementing SOPs & quality documents
• Ability to research, analyze and report independently across a breadth of topics
• Ability to work autonomously and prioritize workflow and flexibility to adjust course when required

Preferred Qualifications:

• Experience supporting regulatory inspections (FDA, EMA, etc.)
• Prior involvement in vendor qualification or supplier quality programs
• Familiarity with data integrity principles
• Strong knowledge of Oncology clinical trials
• Distribution Supply Chain Operations experience

Working Conditions:

• Prolonged periods of sitting at a desk and working on a computer
• US meeting calls may occur outside of normal working hours (in the Hong Kong time zone)