Senior role to plan and implement quality requirements, provide Quality oversight in manufacturing operations at the site, as needed and execute continuous improvements. As part of an inter-departmental team environment, collaborate with subject matter experts to resolve any Quality issues to enable lot disposition or improvements for new and existing clients. Approves Certificate of Testing (CoT), Certificate of Analysis (CoA) and Certificate of Processing (COP) for manufactured batches in accordance with cGMP. Review and approves non-conformances, deviations, and CAPAs that are not batch-specific. Author and revise departmental SOPs to stay current with changes to GxP including FDA, EU and major regulatory bodies as well as guidance documents (i.e., ICH, ISPE, etc.)

• Reviews and approves Change Controls and Document Change Requests
• Review and approves Non-Conformance Events and Deviations that are not batch-specific
• Review and approves Label Specification Sheet (LSS) and Product Specification Sheet (PSS)
• Review and approves executed Aseptic Processing Validation (APV) batch records
• Review and approves APV summary reports
• Approves COAs , COPs or COTs for executed Manufacturing batch records in accordance with cGMP and internal procedures in an efficient and timely manner
• Ensure QA checklist is adequate and comprehensive to enable batchdisposition
• Interacts with QA Manufacturing to provide quality perspective on routine operations and support systems. For example, through facility walk-through and/or output from Quality Management Review
• Interacts with QA Manufacturing to communicate project requirements, an
• timeline to perform batch release
• Writes, reviews and revises SOPs as required
• Participates/Leads internal and client audits, and regulatory inspections
• Participates/Leads internal facility walk-through in manufacturing areas and warehouses
• Participates in quality and process improvement initiatives and project teams
• Given authority to make decisions and sign documents relevant to batches manufactured in WuXi ATU. For example, bulk/finished product declaration.
• Perform duties as assigned by QA Management

Experience / Education

• 10 years of relevant experience in the biopharmaceutical industry
• Bachelors degree in a Science related field preferred

Knowledge / Skills / Abilities:

• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
• Perform well in defined procedures and show progress to independent performance of tasks
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Displays good level of problem solving ability and offer suggestions to superviso on complex issues
• Sound knowledge and interpretation of FDA and EU cGMP requirements
• Extensive experience in writing and/or reviewing/approving Investigations / Deviations / CAPAs preferable
• Ability to work effectively as part of a team and exhibit excellent interpersonal skills.
• Ability to make sound decisions about scheduling, allocation of resources and managing competing priorities
• Flexible in managing deliverables and work hours to meet business objectives.
• Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication

Physical Requirements:

• Must be able to work in Lab setting with Biohazards /various Chemicals
• Must be able to work in an office environment with minimal noise conditions.
• Must be able to wear appropriate PPE and gowning in aseptic conditions
• Must be able to work in environment with variable noise levels
• Ability to stand /Sit/walk for long periods of time
• Ability to crouch, bend, twist, and reach
• Ability to push/pull 20 lbs. occasionally
• Clarity of Vision
• Ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions

WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.