Job Description

JOB PURPOSE

The essential functions include but are not limited to:

• 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 company 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. 

WHAT YOU WILL DO 

Primary Activities include, but are not limited to:

As part of the Global Digital & Data Quality team, the Senior Specialist collaborates 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.

This includes:·       

• Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.

• Interfacing 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.

• Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.

• Providing 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).

• Assuring 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).

• Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.

• Supporting 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.

• Driving resolution of regulatory non-conformance for GxP computerized systems.

• Assuring monitoring of system health, compliance and other metrics are communicated to key stakeholders.

• Promoting GxP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.

• Representing Digital & Data Quality management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.

• Contributing 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.

• Providing Quality Unit review/approval of SDLC documentation.

• Mentor and provide guidance to junior members of the team.

WHAT YOU MUST HAVE

Qualification:

• Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.  

Experience:

• 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. 

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 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.

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Required Skills:

Adaptability, Adaptability, Business Continuity, cGMP Regulations, Change Management, Collaborative Development, Computer System Validation (CSV), Data Quality, Deviation Management, Disaster Recovery Planning, GMP Compliance, Good Automated Manufacturing Practice (GAMP), Manufacturing Quality Control, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance, Product Disposition, Project Management, Quality Auditing, Quality Management Standards, Quality Standards, Regulatory Compliance, Regulatory Requirements, Risk Management, Self Motivation, Six Sigma {+ 2 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/26/2026

*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.