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Senior Manager, Global Quality Engineering and Validation (Hybrid Seattle, WA)

Evotec SE

Evotec SE

Quality Assurance
Multiple locations
Posted on Friday, September 22, 2023

(Hybrid)

Just-Evotec Biologics (JEB) is seeking a highly motivated Sr. Manager, Global Quality Engineering and Validation focused on improving worldwide access to Biotherapeutics! The position will be responsible for providing quality oversight of all validation and qualification activities (Facilities, Utilities, Manufacturing and QC Equipment along with Computerized Systems and IT infrastructure), mentoring and leading a team of Quality Engineers, and building/enhancing the Just-Evotec Validation lifecycle process. This position is part of the Just-Evotec Biologics Quality Leadership team and will report directly to the Global Head of Quality Systems.

Responsibilities

  • Managing Quality Engineering and Validation (QEV) Validation programs for the facilities, utilities, manufacturing and QC lab equipment, computerized systems and associated processes.
  • Responsible for maintaining and ensuring site compliance to corporate policies and procedures for the validation of systems.
  • Perform Validation Risk assessments and Data Integrity evaluations in support of Validation Lifecycle Management (VLM) of equipment, facilities, utilities, processes.
  • Ensure Qualification/Validation activities are completed in accordance with project timelines.
  • Support enterprise, cross functional, and validation activities, in providing approach, methodology, and deliverables in compliance with 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines.
  • Define the validation strategy and associated project plan for systems at JEB and work with the applicable stakeholders to implement and then execute.
  • Oversee future validation efforts associated with the operation of all GMP manufacturing systems, equipment and computer systems. Perform SDLC validation planning for each computerized system to ensure complete, successful end-to-end qualification of electronic systems, including system interfaces and infrastructure usage.
  • Provide oversight to the overall computer system validation master plan, including interactions with other Just-Evotec entities responsible for related non-site-based computer systems.
  • Build, teach, and act as a resource for a team of 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.
  • Perform Validation Risk assessments and Data Integrity evaluations in support of Validation Lifecycle Management (VLM) of equipment, facilities, utilities, processes.
  • 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.
  • Travel to JEB local and international sites as required.

Educational Requirements

  • Bachelor’s or Master’s degree in biological sciences, chemistry, biochemistry, engineering or related life science field.
  • 10+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.
  • 10-15+ years of Quality (QA) or Validation Leadership experience in a GxP regulated environment such as pharmaceuticals, biotechnology or equivalent.

Qualifications

  • Experience with providing quality oversight of GMP computerized systems in the pharmaceutical industry, and pharmaceutical quality systems/quality management systems, including expertise with computer system validation, data integrity, and quality risk management in the pharmaceutical industry.
  • Experience authoring, reviewing, and approving qualification or validation deliverables in a biologics environment.
  • In depth knowledge of 21 CFR 210, 211, ICH Q7, Q9, Q10, Eudralex – volume 4, and Data Integrity and Compliance with cGMP and GAMP.
  • 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.

The base pay range for this position at commencement of employment is expected to be $160,000 to $210,000; Base salary offered may vary depending on individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision and 401k company match, flexible paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.