Senior Specialist, Quality Assurance

Merck • Wilmington, DE

1d • $106,200 - $167,200 • Hybrid

About The Position

The Sr. Specialist Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in all quality-related activities for computerized systems 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 SME’s from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement. The Sr. Specialist DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Requirements

• Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.
• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
• Min 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 in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Must demonstrate 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.
• 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

Nice To Haves

• 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 conversation 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 since of urgency and a proven history producing quality deliverables.
• Ability to respond to changing priorities
• Inclusion behaviors
• Coach and develop others
• Change Management
• Continuous Improvement
• Data Integrity
• Good Automated Manufacturing Practice (GAMP)
• Good Manufacturing Practices (GMP)
• Quality Assurance (QA)
• System Validation

Responsibilities

• Collaborate with stakeholders (e.g., System Owners, Process Owners, Data Owners, Business Unit, Technical Units and Subject Matter Experts) to assess and remediate legacy systems and evaluate / implement new computerized systems, which enable GxP business processes.
• Ensure Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• 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 the 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).
• Assure at-site/above-site system owners have Operating Level Procedures/Plans in place, and are routinely followed to ensure that computerized system(s) remain in a validated status (e.g., problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs (including sufficiently detailed electronic data review/audit trail review instructions for users), disaster recovery plans, business continuity plans).
• Review processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
• Support regulatory inspection and audit activities as needed. This includes the review of audit or 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 or 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.
• Provide Quality Unit review/approval of SDLC documentation.
• Mentor and provide guidance to junior members of the team.

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: Senior