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Associate Director, Quality Assurance (Computer System Validation) - Hybrid

Associate Director, Quality Assurance (Computer System Validation) - Hybrid

MerckRahway, NJ, US
10 days ago
Job type
  • Permanent
Job description

Job Title

As a member of the 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 the Company's Research & Development division.

For our Company Clinical Supply, act as the Quality Unit representative for information technology products such as infrastructure, business applications, laboratory instrument systems, manufacturing automation systems and data analysis packages.

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

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

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

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 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.

Deliver stewardship for the Company 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.

As required, participate in Regulatory Agency inspection activities.

As required, participate as CSV Subject Matter Expert with internal audit program for Clinical Supply areas focusing on business applications, laboratory instrument systems and manufacturing automation systems and related processes.

As required, participate in 3rd party vendor assessments and related follow-up.

Position Qualifications

Education Minimum Requirement :

  • B.S. and / or M.S. degree in an appropriate Life Science, Quality Assurance, 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. GMP) environment.
  • Minimum of twelve 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 as well as equivalent regulations from European Medicines Agency and Health Authorities.
  • 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.
  • Knowledge and understanding of recently published health authority guidance(s).
  • Knowledge of regulatory trends and initiatives such as computer software assurance.
  • Knowledge of emerging technologies, such as AI / ML, and their application to a regulated environment.
  • High level of experience with electronic tools such as software providing document management and testing capabilities.
  • Understanding of Pharma 4.0 and next generation information technology platforms.
  • Ability to prioritize and manage multiple initiatives, projects concurrently while operating in a matrixed organization.
  • 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.

    • Preferred Experience and Skills :

  • Experience with calibration and qualification.
  • Expertise with configuration management.
  • Experience with IT Infrastructure Language and service management.

    • The salary range for this role is $126,500.00 - $199,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

    The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

    We offer a comprehensive package of benefits. Available benefits include 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. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .

    You can apply for this role through https : / / jobs.merck.com / us / en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

    San Francisco Residents Only : We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

    Los Angeles Residents Only : We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

    Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

    Employee Status : Regular

    Relocation : No

    VISA Sponsorship : No

    Travel Requirements : 10%

    Flexible Work Arrangements : Hybrid

    Shift : 1st - Day

    Valid Driving License : Yes

    Hazardous Material(s) : No

    Required Skills : Adaptability, Audit Management, Automated Manufacturing Systems, Biopharmaceutical Industry, Compliance Investigations, Computer Science, Configuration Management (CM), Deviation Management, Document Management, Emerging Technologies, Global Program Development, Good Manufacturing Practices (GMP), Information Technology (IT) Infrastructure, IS Audit, Life Science, Management Process, Project Leadership, Project Risk Assessments, Quality Assurance (QA), Quality Assurance Systems, Quality Management, Quality Oversight, Quality Risk Management, Quality Systems Compliance

    Preferred Skills :

    Job Posting End Date : 10 / 7 / 2025

  • A job posting is effective until 11 : 59 : 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

    • Requisition ID : R366109

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    Director Quality Assurance • Rahway, NJ, US