Associate Director, Quality Assurance

MSD • Durham, PA

3d • Hybrid

About The Position

This is an exciting opportunity for an experienced Quality professional to lead our Digital and Data Quality (DDQ) above site Manufacturing Systems team. The DDQ Associate Director will be responsible for all quality aspects of assigned GMP computerized systems and supporting infrastructure utilized by our Manufacturing Division to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in all quality-related activities for computerized systems used in support of GMP processes and which are required by our Manufacturing Division's Quality Manual or with potential for impact on product quality, patient safety or data integrity. The position will work closely with stakeholders and SMEs from our Manufacturing Division's, Quality operations and IT to provide evidence of quality oversight throughout the computer system lifecycle and must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients. As part of the global DDQ leadership team and reporting to the Director of DDQ, the Associate Director DDQ will be responsible for: Collaborating with stakeholders (e.g., System Owners, Process Owners, Data Owners, and Technical Unit) to assess and select computerized systems which enable GMP business processes. Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency. Interfacing with our Manufacturing Division IT and other internal & external entities to align GMP shop floor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives. Ensuring a risk-based procedure is implemented and executed to provide the independent quality approval of key qualification/validation documentation to ensure compliance with company standards and applicable regulations throughout the computerized system lifecycle. This includes reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are effective. Providing quality and compliance, Data Integrity consultancy and expertise regarding computerized systems and supporting infrastructure to supported areas, systems, and projects. Leading pre-inspection IT readiness and supporting regulatory inspection and audit activities. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems or infrastructure and taking appropriate actions to ensure GMP compliance. Promoting GMP awareness, innovation, and a culture of continuous improvement regarding IT enabled GMP processes and validation activities Driving results, remaining agile and being prepared.

Requirements

• Bachelor's degree in Science (BS) in Information Technology, Engineering or equivalent with eight (8) years of global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment, OR Master’s degree in Science (MS) in Information Technology, Engineering or equivalent with six (6) years of global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment
• Minimum 5 years of experience in managing, delivering and/or supporting validated IT, laboratory and/or process automation solutions.
• Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58, 820, and Data Integrity and local regulatory expectations for assigned areas.
• Extensive knowledge of the principles, theories, and concepts of computerized system validation/compliance
• Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching and team building.
• Experience in leading conversation during regulatory inspections
• Analytical Problem-solving skills applied to issue identification and resolution.
• Ability to understand business needs and map to IT technical solutions.
• Timely decision making
• Ability to respond to changing priorities.

Nice To Haves

• Professional Certifications like Six Sigma and/or a certification in project management (PMP) and/or Security Awareness
• Operate as part of a self-directed team in carrying out day-to-day functions and assigning priorities.
• Business engagement skills, with ability to collaborate with both technical and non-technical roles

Responsibilities

• Collaborating with stakeholders (e.g., System Owners, Process Owners, Data Owners, and Technical Unit) to assess and select computerized systems which enable GMP business processes.
• Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• Interfacing with our Manufacturing Division IT and other internal & external entities to align GMP shop floor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.
• Ensuring a risk-based procedure is implemented and executed to provide the independent quality approval of key qualification/validation documentation to ensure compliance with company standards and applicable regulations throughout the computerized system lifecycle.
• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are effective.
• Providing quality and compliance, Data Integrity consultancy and expertise regarding computerized systems and supporting infrastructure to supported areas, systems, and projects.
• Leading pre-inspection IT readiness and supporting regulatory inspection and audit activities.
• Reviewing audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems or infrastructure and taking appropriate actions to ensure GMP compliance.
• Promoting GMP awareness, innovation, and a culture of continuous improvement regarding IT enabled GMP processes and validation activities.
• Driving results, remaining agile and being prepared.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays, vacation, and compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Manager