Senior Specialist, Quality Assurance

About the role

The Sr. Specialist Digital and Data Quality will oversee the quality aspects of GMP computerized systems and the supporting infrastructure used in various site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations.

Responsibilities

• Collaborate with stakeholders and SMEs from site operations, quality operations, IT, automation, and engineering to assess and remediate legacy systems and evaluate/newly implemented computerized systems enabling GxP business processes.
• Interface with corporate global IT and other internal/external entities to align GxP shopfloor, laboratory, quality system, and/or infrastructure technology capabilities/solutions with quality policies and objectives.
• Ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.
• Provide independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, specifications, reports, and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
• Ensure operating level procedures/plans are in place for system owners and are routinely followed to maintain a validated status (e.g., problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs (including detailed electronic data review/audit trail review instructions for users), disaster recovery plans, business continuity plans).
• Review processes and supporting documentary evidence to verify compliance activities related to computerized systems are in place and effective.
• Support regulatory inspection and audit activities as needed, including reviewing audit/inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems, and infrastructure (at local site), and taking appropriate actions to ensure GxP compliance.
• Drive resolution of regulatory non-conformance for GxP computerized systems.
• Assure monitoring of system health, compliance, and other metrics are communicated to key stakeholders.
• Promote GxP awareness and a culture of continuous improvement and facilitate manufacturing process improvements, laboratory operational excellence, and validation activities, including latest trends in validation and best practices.
• Represent Digital & Data Quality management upon request in local site/system-specific meetings regarding computerized systems selection, operation, and/or compliance-related issues.
• Contribute to the development and/or maintenance of training programs in the principles of computerized systems validation, computer software assurance, and regulatory requirements in validation, data integrity, ALCOA principles, maintenance, and use of computerized systems.
• Mentor and provide guidance to junior members of the team.

Qualifications

• Bachelor's degree in Science, Information Technology, Engineering, or equivalent.
• Preferably hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure, and/or laboratory operations.
• At least 5 years of experience in regulated pharmaceutical manufacturing industry.
• At least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.
• Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis on 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Extensive knowledge of the principles, theories, and concepts of computerized system validation/compliance.
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
• Limited supervision required in day-to-day activities.

Preferred Competencies and Skills

• Professional Certifications (e.g. Six Sigma or certification in Project Management (PMP))
• Operate as part of a self-directed team in carrying out day-to-day functions and assigning priorities
• Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & Operations
• Hands-on experience in a Quality and/or Compliance role in a GMP environment
• Business engagement skills, with ability to collaborate with both technical and non-technical roles
• Multi-lingual capabilities preferred
• Experience in leading conversations during regulatory inspections
• Excellent oral and written communication skills including persuading others and developing cross-functional relationships both at site and across sites
• Analytical problem-solving skills applied to issue identification and resolution
• Listening, integrating diverse perspectives, adds value to the achievement of team goals
• Timely decision-making
• Project management skills combined with a sense of urgency and a proven history producing quality deliverables
• Able to respond to changing priorities
• Inclusion behaviors
• Coach and develop others

Required Skills

• Adaptability
• Aseptic Operations
• Business Continuity
• cGMP Compliance
• Computer System Validation (CSV)
• Data Analysis
• Data Quality
• Disaster Recovery Planning
• Driving Continuous Improvement
• Environmental Monitoring
• GMP Compliance
• Manufacturing Process Improvements
• Motivation Management
• Pharmaceutical Manufacturing
• Pharmacy Regulation
• Professional Integrity
• Project Management
• Quality Auditing
• Quality Inspections
• Regulatory Compliance
• Regulatory Requirements
• Sterile Manufacturing
• System Health Monitoring
• Technical Writing
• Working Independently

Preferred Skills

• Change Management
• Continuous Improvement
• Data Integrity
• Good Automated Manufacturing Practice (GAMP)
• Good Manufacturing Practices (GMP)
• Quality Assurance (QA)
• System Validation