Job Description
This is an exciting opportunity for an experienced Quality professional to lead our Digital and Data Quality (DDQ) above site Manufacturing Systems team. The DDQ Associate Director will be responsible for all quality aspects of assigned GMP computerized systems and supporting infrastructure utilized by our Manufacturing Division to ensure compliance with company policies, procedures and regulatory expectations, this includes involvement in all quality-related activities for computerized systems used in support of GMP processes and which are required by our Manufacturing Division's Quality Manual or with potential for impact on product quality, patient safety or data integrity.
The position will work closely with stakeholders and SMEs from our Manufacturing Division's, Quality operations and IT to provide evidence of quality oversight throughout the computer system lifecycle and must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.
As part of the global DDQ leadership team and reporting to the Director of DDQ, the Associate Director DDQ will be responsible for:
Collaborating with stakeholders (e.g., System Owners, Process Owners, Data Owners, and Technical Unit) to assess and select computerized systems which enable GMP business processes.
Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
Interfacing with our Manufacturing Division IT and other internal & external entities to align GMP shop floor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.
Ensuring a risk-based procedure is implemented and executed to provide the independent quality approval of key qualification/validation documentation to ensure compliance with company standards and applicable regulations throughout the computerized system lifecycle. This includes reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are effective.
Providing quality and compliance, Data Integrity consultancy and expertise regarding computerized systems and supporting infrastructure to supported areas, systems, and projects.
Leading pre-inspection IT readiness and supporting regulatory inspection and audit activities. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems or infrastructure and taking appropriate actions to ensure GMP compliance.
Promoting GMP awareness, innovation, and a culture of continuous improvement regarding IT enabled GMP processes and validation activities
Driving results, remaining agile and being prepared
Minimum Education Requirements and Experience:
Bachelor's degree in Science (BS) in Information Technology, Engineering or equivalent with eight (8) years of global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment, OR
Master’s degree in Science (MS) in Information Technology, Engineering or equivalent with six (6) years of global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment
Required Experience and Skills:
Minimum 5 years of experience in managing, delivering and/or supporting validated IT, laboratory and/or process automation solutions.
Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58, 820, and Data Integrity and local regulatory expectations for assigned areas.
Extensive knowledge of the principles, theories, and concepts of computerized system validation/compliance
Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching and team building.
Experience in leading conversation during regulatory inspections
Analytical Problem-solving skills applied to issue identification and resolution.
Ability to understand business needs and map to IT technical solutions.
Timely decision making
Ability to respond to changing priorities.
Preferred Experience and Skills:
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.
Business engagement skills, with ability to collaborate with both technical and non-technical roles
VETJOBS
Required Skills:
Active Listening, Active Listening, Biopharmaceuticals, Change Management, Collaborative Leadership, Computer System Validation (CSV), Decision Making, Driving Continuous Improvement, GMP Compliance, GMP Laboratory, Immunotherapy, Laboratory Automation, People Leadership, Performance Qualification (PQ), Project Management, Quality Auditing, Quality Control Documentation, Quality Management Standards, Quality Management Systems (QMS), Quality Risk Management, Regulatory Compliance, Regulatory Inspections, Security Awareness, Six Sigma, Stakeholder Engagement {+ 1 more}Preferred Skills:
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The salary range for this role is
$142,400.00 - $224,100.00This 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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
05/30/2026*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.