Job Description

Digital & Data Quality (DDQ) GMP AI Compliance Director

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. Join our team and contribute to our mission of using the power of leading-edge science to save and improve lives around the world.

Responsibilities

Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations.
Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, vendor assessment, human-in-the-loop role, technology-specific requirements, data retention, and periodic monitoring.
Sponsor and, where appropriate, lead development of policies and procedures for validation and monitoring of GMP/GDP AI-based tools and applications.
Partner with relevant stakeholders across our manufacturing division, our research & development division, and IT to develop common frameworks and champion use of common solutions across the divisions.
Collaborate with relevant stakeholders and provide input into GMP classification, risk assessment, validation, and monitoring strategies for AI-based tools and applications proposed for use at our manufacturing division.
Provide and/or coordinate quality oversight of GMP AI-based tools and applications to ensure validation efforts focus on intended use and maintaining the validated state, including human-in-the-loop role, periodic monitoring, output reliability, and explainability.
Actively drive and participate in external engagements to benchmark and align with industry peers.
Experiment with AI technologies and pursue opportunities to employ AI-based tools in DDQ operations.
Contribute to the DDQ strategy, team development, and continuous improvement of DDQ-owned processes as a member of the DDQ Leadership Team.
Manage escalations effectively and efficiently.
Manage DDQ resources, participate in hiring, training, and management of DDQ departmental employees, coach direct reports and other team members, and align team and individual goals with departmental and company objectives.
Model and reinforce our company’s leadership behaviors, values, and culture.

Qualifications

Required

Bachelor's degree in Science, Information Technology, Engineering, or equivalent (Advanced Degree preferred) with a minimum of twelve (12) years’ global and site experience in an FDA and/or EU regulated pharmaceutical, vaccine, biologics, or API manufacturing environment.
Expert knowledge of relevant regulations (FDA/EU/ICH/WHO), with emphasis on emerging AI regulations and guidance; 21 CFR Part 11, 210, 211, EU Annex 11 and Annex 15, data integrity, and local regulatory expectations as well as industry standards, such as GAMP.
Thorough understanding of current regulatory trends in GMP AI, data integrity, and computerized systems.
Extensive knowledge of the principles of quality risk management and data management.
Proven track record of formulation and implementation of validation strategies for novel technologies.
Understanding of a range of AI technologies, model performance assessments, explainability techniques, and model monitoring tools (hands-on experience preferred).
Business engagement skills, with the ability to collaborate with both technical and non-technical roles. Proficiency in negotiation, facilitation, building cross-functional relationships, and influencing others.
Training and coaching skills.

Preferred

Professional experience in culturally diverse environments.
Industry collaboration.
Lean Six Sigma, Project management (PMP), or other applicable professional certifications preferred.
Experience overseeing self-directed teams in carrying out day-to-day functions and assigning priorities and aligning reporting team(s) with strategic priorities.
Collaborative leadership style with an emphasis on listening, integrating diverse perspectives, coaching, and team building.
Experience in leading conversations during regulatory inspections.
Excellent communication and presentation skills.
Analytical problem-solving and root cause analysis skills.
Adaptability and decisiveness. Ability to respond to changing business priorities, technologies, and regulations.

This role is associated to a 25% travel.

Direct reports: 1-5

Required Skills:

Active Listening, Active Listening, AI Governance, AI Systems, Applied Engineering, Artificial Intelligence (AI), Artificial Intelligence Software, Artificial Intelligence Techniques, cGMP Compliance, Change Management, Coaching, Communication, Data Integrity, Data Quality, Decision Making, Escalation Management, GMP Compliance, Information Communication Technology (ICT), Interpersonal Relationships, Leadership, Listening Comprehension, Management Process, Manufacturing Quality Control, Operational Efficiency, People Leadership {+ 16 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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 salary range for this role is

$173,200.00 - $272,600.00

This 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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

*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.

Requisition ID:R390815

Digital & Data Quality (DDQ) GMP AI Compliance Director

Benefits

Job Description