Senior Specialist, Quality Assurance - Hybrid

Job Description

Position Description:

• As a member of our Company's Research Laboratories Quality Assurance community, provide for and lead Quality Assurance oversight for computer system validation matters within the Global Development Quality organization and for our Company's R&D division.

• For our Company's Clinical Supply, act as the Quality Unit representative for information technology products such as infrastructure, business applications, end-user applications, laboratory instrument systems and manufacturing automation systems.

• Provide independent Quality Assurance oversight for the implementation of new computerized systems, change control involved with existing computerized systems as well as the retirement of computerized systems in the Clinical Supply domain.

• Develop and maintain a subject matter expert level of understanding for our Company Policies, Procedures and Quality Manuals governing computer system validation activities.

• Endorse and build Quality Management System elements into the end-to-end computer system validation process, thereby promoting permanent inspection readiness.

• Consult, assess and assist with risk based, tailored approaches for computer system validation activities and testing.

• Develop and maintain an overall computer system validation posture and program for a defined functional area(s) (single point of contact) within Clinical Supply, including support for System Development Life Cycle deliverables and testing.

• Act as a liaison with respect to the Quality Management System and Compliance pillars of Global Development Quality for the purposes of investigations, corrective action/preventive action, procedural controls, auditing and Quality Risk Management.

• As required, participate in Regulatory Agency inspection activities.

• Deliver stewardship for our corporate initiatives from a Quality Assurance perspective, such as the Data Governance and Corporate Resiliency programs.

• Identify and incorporate continuous improvements into computer system validation activities and standards. Leverage external affiliations in order to evaluate current trends.

• Collaborate and establish relationships with key stakeholders in the Business and Technical Units, including external suppliers.

Position Qualifications:

Education Minimum Requirement:

• B.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.

Required Experience and Skills:

• Experience working in a Pharmaceutical/Biotechnology industry; experience working in a health authority regulated (e.g., GLP, GMP) environment.

• 5 years of industry experience including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.

• High level of expertise and exposure with agency regulations, such as 21 CFR Part 11, Part 58, Part 210, Part 211 from the US Food and Drug Administration.

• High level of expertise in SLC methodology (e.g., V-model, waterfall, agile, spiral) including change management.

• Extensive experience providing oversight for adherence to enterprise SLC and procedures.

• Proficient skills dealing with and understanding typical laboratory facilities and equipment.

• Proficient skills dealing with and understanding automation systems found on the operations shop floor.

• Understanding of Pharma 4.0 and next generation information technology platforms.

• Ability to prioritize and manage multiple initiatives, projects concurrently.

• Excellent interpersonal skills including ability to work as a team member in a collaborative environment.

• Excellent written and communication skills including thorough knowledge of Good Documentation Practices.

• Possess excellent time management skills.

• High attention to detail.

Preferred Experience and Skills:

• Experience with calibration and qualification.

• Expertise with configuration management.

• Knowledge of published regulatory agency data integrity, cloud computing, artificial intelligence guidance.

• Moderate level of experience with electronic tools such as software providing document/content management and testing capabilities.

• Some level of experience with IT Infrastructure Language and service management.

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