Associate Director – Digital & Data Quality, Hybrid

Job Description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We’re at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. As an Associate Director Digital and Data Quality, you will play a vital role in ensuring compliance with our company’s policies, procedures, and regulatory expectations. 

Your Core Responsibilities 

• Provide quality, compliance, and Data Integrity consultancy for computerized systems and supporting infrastructure.  

• Align GMP shopfloor, laboratory, quality system, and infrastructure technology capabilities with quality policies and objectives. 

• Implement risk-based methodologies for independent quality approval of key qualification/validation documentation to ensure compliance. 

• Promote GMP awareness, innovation, and continuous improvement in IT-enabled GMP processes and validation activities.  

• Collaborate with stakeholders to assess and select computerized systems for GMP business processes, ensuring technologies meet business needs and encourage innovation. 

• Contribute to large multifunctional project teams, aligning goals with regulatory expectations and our manufacturing division’s quality objectives. 

• Lead pre-inspection IT readiness and support regulatory inspection and audit activities. 

Who You Are 

You are ready if you have: 

• Bachelor’s, Master’s, or PhD in Science, IT, Engineering, Business, or equivalent with relevant years of experience in regulated pharmaceutical manufacturing and delivering validated enterprise systems. 

• Direct experience with enterprise systems supporting pharmaceutical manufacturing operations, especially shared systems across multiple legal entities. 

• Strong verbal and written communication skills. 

• In-depth understanding of current pharmaceutical industry regulations (FDA/EU/ICH), including 21 CFR Part 11, 210, 211, 58, 820, and Data Integrity. 

• Extensive knowledge of computerized system validation/compliance principles, theories, and concepts. 

• Familiarity with implementing quality systems in pharmaceutical, laboratory, or biotechnology manufacturing environments, and understanding of QRM concepts and Agile Methodologies. 

Nice to have, but not essential: 

• Professional Certifications like Six Sigma and/or a certification in project management (PMP) and/or Security Awareness. 

• Operate as part of a self-directed team in carrying out day-to-day functions and assigning priorities. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.  

As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don’t hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.  

We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.  

Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model 

So, if you are ready to: 

Invent solutions to meet unmet healthcare needs, please apply today. 

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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/17/2025

*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.