Associate Director - Digital and Data Quality

Job Description

The Associate Director Digital and Data Quality 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.

Primary Activities include, but are not limited to:

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• 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 MD IT and other internal & external entities to align GMP 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
• 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 or playing a significant role on large multifunctional project teams
• Seeking to understand each team member’s unique contribution and role
• Aligning team goals with regulatory expectations and our Manufacturing Division's quality objectives | Developing a robust escalation process for identified risks to compliance or tasks on project critical paths are communicated
• 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
• Representing Digital and Data Quality Management in local and above site meetings regarding computerized systems selection, operation and/or compliance related issues | This includes driving resolution to regulatory non-conformance of GMP systems
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders
• Promoting GMP awareness, innovation, and a culture of continuous improvement regarding IT enabled GMP processes and validation activities
• Maintaining, updating, enhancing quality SDLC processes supporting our Manufacturing Division's computerized systems | This includes exercising the authority and influence to standardize processes globally
• Driving the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems
• Effectively and efficiently managing Digital and Data Quality resources | This includes training and coaching Digital and Data Quality employees
• Driving results, remaining agile and being prepared

Minimum Education Requirement and Experience

• Bachelor’s degree in science, Information Technology, Engineering, Business or equivalent with eight (8) years’ experience in regulated pharmaceutical manufacturing and delivering validated enterprise systems OR
• Master’s degree in science, Information Technology, Engineering, Business or equivalent with six (6) years’ experience in regulated pharmaceutical manufacturing and delivering validated enterprise systems OR
• PhD in Science, Information Technology, Engineering, Business or equivalent with three (3) years’ experience in regulated pharmaceutical manufacturing and delivering validated enterprise systems

Required Experience and Skills

• Direct experience with and understanding of enterprise systems supporting pharmaceutical manufacturing operations, especially shared systems across multiple legal entities (companies)
• Principled verbal and written communications
• 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 
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment
• Good understanding of QRM concepts and Agile Methodologies

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
• Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching and team building
• Good understanding of GMP and Engineering Standards related to computerized systems development, implementation, and operations
• Business engagement skills, with ability to collaborate with both technical and non-technical roles
• Multi-lingual capabilities
• 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

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

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Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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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. 

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