Job Description

An opportunity has arisen for a Director, Digital & Data Quality - Europe. The successful candidate will direct the regional DDQ organization and will be responsible for the management of all quality aspects of GMP computerized systems and supporting infrastructure utilized by our Manufacturing Division in assigned areas to ensure compliance with company policies, procedures and regulatory expectations. This includes oversight of all quality-related activities for computerized systems used in support of GMP processes and which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety and data integrity.

The position will work closely with stakeholders and management from Quality Operations, Business Units, External, Manufacturing and Information Technology. The DDQ Director must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Building and maintaining relationships with the relevant leadership teams, actively influencing change and alignment across the organization in order to maintain compliance with the regulatory and QMS expectations for the computerized systems, including data analytics tools and new technologies
• Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess, select and implement computerized systems which enable GMP business processes
• Ensuring technologies selected meet the high-level business process and compliance needs while encouraging innovation, efficiency and streamlined digital user experience
• Interfacing with or Company 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 high degree of collaboration with relevant leaders for managing portfolio of projects and large-scale initiatives, including budgets
• Actively contributing to the creation of strategies for the validation of new facilities, systems and technologies, ensuring standardized risk-based approach to computerized systems compliance across projects and sites
• Collaborating with key stakeholders to continuously improve and drive implementation of scalable, risk-based policies to computerized systems compliance throughout their lifecycle, ensuring that systems are validated for their intended use
• Identifying leveraging and improvement opportunities, and taking active role in their implementation
• Ensuring that the DDQ organization provide independent, effective and efficient oversight of GMP computerized systems, including, but not limited to, validation documentation, data integrity controls, SOPs, change controls and deviations
• Managing escalations in an effective and efficient manner
• Supporting regulatory inspections and audits
• Effectively and efficiently managing DDQ resources | Participates in the hiring, training and management of DDQ departmental employees | Coaching direct reports | Proactively aligning team or individual goals with regulatory expectations and our Manufacturing Division quality objectives | Modeling and reinforcing our Company’s leadership behaviors, values and culture

Education

• Bachelor's degree in computing, engineering or related areas of study.
• Required
• Twelve years global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics or API manufacturing environment
• Five years experience managing, delivering and/or supporting validated IT, laboratory and/or automation solutions
• Excellent understanding of regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, 58 and 820, data integrity expectations and local regulations for assigned areas
• Extensive knowledge and hands-on experience of the principles, theories and concepts of computerized system validation and compliance
• Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment
• In depth understanding of laboratory, manufacturing, automation, infrastructure and/or information systems in a regulated environment

Preferred

• Lean Six Sigma, Project management (PMP), or other applicable professional certifications
• Experience overseeing self-directed teams 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
• Business engagement skills, with ability to collaborate with both technical and non-technical roles | Proficient in negotiation, facilitation, building cross-functional relationships and influencing others
• Experience in leading conversation during regulatory inspections
• Principled communication verbal and written communication skills
• Analytical problem-solving skills
• Ability to understand business needs, a wide range of technologies and how they map to IT technical solutions
• Adaptable and decisive | Ability to respond to changing business priorities, technologies and regulations

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R215657