Manager/Sr. Manager, Quality Engineering & Validation (QEV)

Just is seeking a highly motivated leader to join the Global Quality Engineering and Validation organization that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role within the QEV organization will be focused on Computer System Validation (CSV) and will be primarily responsible for building a CSV QEV team, mentoring a team of Quality Engineers, and building/enhancing the Just-Evotec CSV program. This role will build, provide guidance, and develop solutions for enterprise and local computerized systems validation in a GxP regulated biologics environment within the Just-Evotec manufacturing network.

Responsibilities

• Support enterprise, cross functional, and local computer systems validation activities, in providing approach, methodology, and deliverables in compliance with GxP, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Define the strategy for computer system validation at Just-Evotec and work with stakeholders to implement.
• Build, teach, and act as a resource for a team of 1-3 Quality Engineers with varying experience levels.
• Develop compliant novel ways to comply with regulatory requirements.
• Partner with project teams to provide solutions for validation of systems following a risk-based approach as established in Just-Evotec policy documents and procedures.
• Apply extensive knowledge of technical & validation (PQS) standards/requirements and industry guidance to influence the interpretation of governing requirements as it relates to computer system validation.
• Implement and maintain the PQS as it pertains to systems validation for Just.
• Oversee validation documents (plans, qualification, UAT, test cases, traceability matrix, and summary reports) with functional teams, ensuring the documentation meets compliance requirements and quality standards.
• Provide Quality oversight in change control activities to ensure technical and document impact assessments are performed in a compliant manner and the regulated systems are maintained in a validated state.
• Provide Quality guidance, strategy, and presentation of topics during external audits.

Qualifications and Educational Requirements

The right candidate will possess the following skills and experience.

• Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering or related life science field.

• 8+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
• Proven work experience in computer software validation
• Experience authoring, reviewing, and approving qualification or validation deliverables in a biologics environment.
• Knowledge of FDA guidance’s and industry standards (e.g. quality Systems, GAMP, 21 CFR Part 11 and EudraLex Volume 4 Annex 11).
• Knowledge of Data Integrity principles and applications in computer systems.
• Solid technical understanding of GMP biologics manufacturing processes and equipment.
• Proven track record to create, review, and execute qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances/deviations.
• Experience presenting and defending topics to external auditors around qualification and validation strategies.
• The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
• Involvement with both technical and quality aspects of biologics manufacturing.
• Knowledge and expertise to solve complex technical problems.
• Significant experience navigating and managing various modules in a Quality Management System software suite.
• Excellent verbal and written communication skills.
• Strong focus on quality and attention to detail.
• Possess effective task/time management organization skills
• Capacity to develop solutions to technical issues of moderate to complex scope.