Senior Specialist Quality Assurance

MSD•Wilmington, DE

2d•$106,200 - $167,200•Hybrid

About The Position

The Senior Specialist Digital and Data Quality is responsible for quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories. The role ensures compliance with company policies, procedures, and regulatory expectations for computerized systems required by the manufacturing division's Quality Manual or with potential impact on product quality, patient safety, or data integrity. As part of the Global Digital & Data Quality team, the Senior Specialist works with stakeholders across site operations, quality operations, IT, automation, engineering, system and process ownership, and subject matter experts. The role provides independent quality oversight throughout the computerized system lifecycle, supports assessment and remediation of legacy systems and implementation of new systems, and promotes continuous improvement. The position is expected to conduct its duties independently, with integrity, fairness, and objectivity to protect products and patients.

Requirements

Bachelor's degree.
Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure, and/or laboratory operations.
At least 5 years of experience in the regulated pharmaceutical manufacturing industry.
At least 3 years of experience delivering validated IT solutions or working in an application support role in a regulated environment.
Strong understanding of the pharmaceutical industry and applicable FDA, EU, and ICH regulations, especially 21 CFR Parts 11, 210, 211, and 820, and local regulatory expectations.
Extensive knowledge of the principles, theories, and concepts of computerized system validation and compliance.
Familiarity and practical experience implementing quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
Ability to work with limited supervision in day-to-day activities.
Ability to operate as part of a self-directed team, carry out daily functions, and assign priorities.
Business engagement skills and ability to collaborate with technical and non-technical roles.
Excellent oral and written communication skills, including persuading others and developing cross-functional relationships at and across sites.
Analytical problem-solving skills applied to issue identification and resolution.
Ability to listen, integrate perspectives, and contribute to team goals.
Timely decision-making and ability to respond to changing priorities.
Project management skills, a sense of urgency, and a proven history of producing quality deliverables.
Inclusion behaviors and ability to coach and develop others.
Skills listed include active listening, adaptability, cGMP regulations, change management, coaching, computer system validation, data integrity and quality, deviation management, GMP compliance and documentation, GMP guidelines and validation, GAMP, government regulation, IT, manufacturing quality control, peer mentoring, pharmaceutical quality assurance, prioritization, problem analysis and identification, procedure adherence, and product disposition.

Nice To Haves

Bachelor's degree preferably in Science, Information Technology, Engineering, or equivalent.
Professional certifications, such as Six Sigma or Project Management Professional (PMP).
Good understanding of applicable engineering, laboratory, or standards-related requirements for computerized-system development, implementation, and operations.
Hands-on experience in a Quality and/or Compliance role in a GMP environment.
Multilingual capabilities.
Experience leading conversations during regulatory inspections.

Responsibilities

Collaborate with system owners, process owners, data owners, business units, technical units, and subject matter experts to assess and remediate legacy systems and evaluate or implement computerized systems that enable GxP business processes.
Ensure selected technologies meet high-level business needs while encouraging innovation and efficiency.
Coordinate with Corporate Global IT and internal and external entities to align GxP shopfloor, laboratory, quality-system, and infrastructure technology capabilities and solutions with quality policies and objectives.
Ensure initial project tailoring is appropriate to project complexity and risk and accommodates the full scope of work.
Independently review and approve key qualification and validation documentation, including policies, procedures, acceptance criteria, plans, protocols, specifications, reports, and computerized-system-related changes, to ensure compliance throughout the system lifecycle.
Ensure system owners have operating-level procedures and plans in place and routinely follow them to keep computerized systems in a validated state, including processes for incident management, change control, periodic review, investigations, backup and restore, system use and administration, electronic-data and audit-trail review, disaster recovery, and business continuity.
Review processes and supporting documentary evidence to verify that computerized-system compliance activities are in place and effective.
Support regulatory inspections and audits, including reviewing reports, responding to findings involving IT applications, automated manufacturing equipment, laboratory systems, and site infrastructure, and taking appropriate actions to ensure GxP compliance.
Drive resolution of regulatory non-conformance for GxP computerized systems.
Ensure monitoring of system health, compliance, and other metrics is communicated to key stakeholders.
Promote GxP awareness and continuous improvement, and facilitate manufacturing process improvements, laboratory operational excellence, and validation activities using current trends and best practices.
Represent Digital & Data Quality management in local-site or system-specific meetings concerning computerized-system selection, operation, or compliance issues, as requested.
Contribute to developing and maintaining training programs covering computerized systems validation, computer software assurance, validation regulations, data integrity, ALCOA principles, and computerized-system maintenance and use.
Provide Quality Unit review and approval of SDLC documentation.
Mentor and guide junior team members.