Director, Quality Compliance
Just-Evotec Biologics is seeking a highly motivated Quality Assurance Compliance Officer that desires to be part of a team focused on improving worldwide access to Biotherapeutics! The role is responsible for advancing the state of compliance in preparation for commercial operations. Responsibilities include providing technical and quality oversight of computer system qualification, validation, and assurance activities, collaboration with functional leaders to advance compliance to best in class status, and facilitate inspection readiness.
- Define and build Quality business processes and standards by working with the relevant Automation and IT teams.
- Partner with the biologics manufacturing sites on the implementation of new manufacturing and quality systems.
- Develop compliant novel ways to comply with regulatory requirements while embracing lean operational methodologies.
- Lead the inspection readiness efforts in preparation for internal and client audits, regulatory inspections, and commercial operations.
- Lead and host compliance audits and regulatory inspections by competent regulatory authorities (e.g., FDA, EMEA, PMDA, MHRA, etc.)
- Harmonize PQS across Global Biologics operations.
- Apply quality risk management principles and phase appropriate compliance to situations as the needs arise.
- Review and approve qualification documents, before and after execution, as required.
- Ensure current Good Manufacturing Practice (cGMP) regulations and Just PQS requirements are met for qualification/validation of manufacturing execution systems, process automation systems and related GMP computerized systems.
- Apply knowledge of GMP computerized systems, qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards.
- Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance.
- BA/BS or higher degree in engineering or life sciences with at least 10+ years’ experience in the pharmaceutical industry in the fields of engineering or qualification, including the design, implementation, commissioning, qualification/validation and maintenance of GMP computerized systems and Pharmaceutical Quality Systems.
- Both high-level and detailed knowledge of SDLC approaches (such as GAMP 5) and computer system validation concepts. Ability to interact with all levels in the organization.
- The successful candidate must have strong initiative and integrity as well as strong interpersonal, written and verbal communication skills. They should be able to successfully work independently and within teams, demonstrate strong problem-solving skills, partner/customer focus, and the ability to work with complex business systems and processes.
- Expert in 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.
- Expert knowledge of relevant health authority requirements/guidance and industry standards ISA S88 and ISA S95 for batch control and enterprise-control system integration; ISPE GAMP, ISPE Baseline Guide: Commissioning and Qualification, and ASTM E2500.
- High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical automation field and understanding of quality risk management principles.
- Experience with the integration of Manufacturing Execution Systems (MES) with Process Automation Systems (PAS), Enterprise Resource Planning (ERP) systems, Laboratory Information Management Systems (LIMS), and lot disposition systems
- Knowledge of the Drug Substance manufacturing process and process (equipment) systems in the biopharmaceutical industry as well as key business processes including review by exception, electronic batch production records/batch reports, materials management, and sample management in the pharmaceutical industry.
- Experience with the design, implementation, commissioning, qualification/validation and maintenance of Manufacturing Execution Systems (MES), and/or Process Automation Systems (PAS). Experience or familiarity with Korber Werum PAS|X MES and Emerson DeltaV PAS is preferred.
- Experience with health authority inspections demonstrating their expertise and the successful defense of GMP computerized systems.
- Mastery of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
- Familiarity with agile software development approaches, and the lifecycle management of GMP computerized systems in the pharmaceutical industry.