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.
