Title:  Principal, Quality Assurance, GMP

Job Summary

The Principal, Quality Assurance, GMP role focuses on ensuring compliance with cGMP standards within the WSS laboratories by identifying gaps, developing solutions, and overseeing their implementation. Collaborating with key stakeholders, the position ensures all improvements align with global quality and laboratory requirements. The role requires providing expert guidance on regulatory and industry standards concerning data integrity, including computer system validation, audit trails, electronic signatures, and data storage and retention.

Essential Duties and Responsibilities

• Responsible to identify gaps, formulate solutions, and drive closure to achieve and maintain compliance with cGMP standards within the WSS laboratories.
• Partner with key stakeholders to ensure that identified improvements are aligned with strategic global quality and lab requirements. 
• Provide expertise and guidance for regulatory and industry expectations in terms of data integrity requirements: computer system validation, audit trail, electronic signature, data storage and retention.
• Perform recurring laboratory audits of quality test methods and results per established West procedures to confirm they are globally harmonized with respect to data recording and documentation.
• Identify and implement meaningful metrics and KPI’s to measure and improve WSS laboratory compliance.
• Provide guidance to QA and WSS Lab during regulatory and client audits on issues related to Data Integrity and Computer System Validation (CSV).
• Actively engage with the laboratory team to drive the completion of investigations and manage backlog when necessary; regularly analyze data trends to implement improvements and ensure customer expectations are met through effective reporting and communication.
• Assist the QA Manager by ensuring WSS team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations.

Education

• Bachelor’s Degree and/or Masters in Science Technology or Engineering.
• Master's Degree preferred

Work Experience

• 8 years of quality-related experience with preferred experience in pharmaceutical and/or medical device industry
• Expertise of cGMP requirements, ISO standards and FDA regulations

Preferred Knowledge, Skills and Abilities

• Create multifaceted Laboratory procedures on GMP related topics such as data documentation, processes, documentation templates, etc., in alignment with global laboratory strategies.
• Perform Expert-Level GMP review and approval of global laboratory documentation, i.e. check for compliance of Lab Records to cGMP requirements related to the activities of the global SME group.
• Expertise of cGMP requirements, ISO standards, FDA regulations, and quality systems such as ISO 13485, ISO 9001, ISO 15378, 21 CFR 820, 21 CFR 11, ISO 14971
• Working knowledge of various analytical instruments software and integration with LabVantage LIMS, Waters Nugenesis SDMS and Waters Empower desired.
• Familiarity with MasterControl, SAP and working knowledge of statistical data analysis
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Ability to work independently, multi-task and thrive in fast-paced environment.
• Thorough understanding of validation activities and risk management principles and techniques
• Fluent in English
• Excellent written and verbal communication skills
• Strong problem-solving and critical thinking skills
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times.

Travel Requirements

Physical Requirements

Additional Requirements

• Adaptable to changes in the work environment, able to manage competing demands and deal with frequent change, delays, or unexpected events.
• Must maintain the ability to work well with others in a variety of situations.
• Maintain high attention to detail, accuracy, and overall quality of work.
• Must be able to understand and adhere to established procedures, multi-task, work under time constraints, problem solve, and prioritize.
• Effectively communicate and interface with various levels internally and with clients.