Description

• Act as the primary point of contact for QA-related topics for both customers and internal stakeholders.
• Provide routine updates to customers on QA-relevant topics (e.g., weekly deviation updates).
• Attend and contribute constructively in internal and external customer project meetings.
• Coordinate and deliver product-specific documents (e.g., Quality Agreements, Product Quality Reviews, or similar reports) in a timely manner to meet customer satisfaction.
• Coordinate and present quality reviews to internal stakeholders and customers as required.
• Lead investigations for customer complaints and ensure records are closed in accordance with customer requirements and internal SOPs.
• Provide QA oversight in customer project-related activities, including review and approval of product-specific documents or Trackwise records outside of routine operations, ensuring accuracy, timely delivery, and compliance with quality requirements. Examples include but are not limited to: PQR, sampling plans, control plans, process descriptions, BLA content, new product introductions, customer suspension/decommissioning, product recalls, and OOS records.
• Provide QA Operations oversight to site-wide improvement projects.
• Participate in and/or lead resolution of complex process or project issues.
• Guide and coach junior members of the QA team.
• Formulate and articulate solutions to issues/problems for internal/external teams and management.
• Represent QA Operations in cross-functional decision-making meetings (internal and external).

Qualifications

• Degree/Diploma in Life Sciences, Biotechnology, Chemistry, or related discipline.
• Relevant QA experience in the pharmaceutical, biotech, or related life sciences industry.
• Strong understanding of cGMP requirements and QA processes.
• Proven ability to manage customer interactions and deliver quality documentation in a timely manner.
• Excellent problem-solving skills with the ability to resolve complex issues.
• Strong communication and interpersonal skills to work effectively with cross-functional teams.
• Experience in mentoring or coaching team members is an advantage.