MSD Director Quality Operations Technology Digital Strategy Lead Hybrid 

United States, Upper Gwynedd Township 

70962682

Job Description

The mission of our company’s Research Laboratory Quality Assurance is to: safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures, and to provide independent assurance that delivers high quality data and clinical supplies.

Clinical Supplies Quality Operations and Technology is part of the larger Global Development Quality organization that is responsible for oversight of manufacturing, packaging and distribution activities for the clinical supply chain, ensuring compliant, reliable supply to our trials and patients.

The Quality Operations and Technology Digital Strategy Lead reports to the Senior Director, Clinical Supply Quality Operations and Technology and is accountable for partnering with CMC colleagues to define and execute a Digital Strategy for Global Development Quality.

Key duties of this role include, but are not limited to:

• Develop and oversee the execution of the GDQ Digital Quality Operations Strategy leveraging AI/Automation and data to simplify workflows and enhance user experiences.

• Define quality standards and specifications for data platforms, data management and digital assets.

• Deliver technology enabled laboratories enabling simplification, standardization and instrumentation / system connections.

• Deliver the seamless integration of digital solutions with manufacturing and quality systems, processes, workflows and data analytics.

• Lead cross-functional efforts to assess and manage use cases and adopt AI for GMP application.

• Provide leadership and guidance to cross-functional teams in the implementation of digital projects, ensuring successful delivery on time and within budget.

• Collaborate with internal and external stakeholders to ensure compliance with regulatory requirements and industry best practices in the use of digital solutions for the clinical supply chain.

• Monitor and evaluate the performance of digital initiatives, tracking key metrics, and providing recommendations for continuous improvement.

• Stay updated on industry trends, emerging technologies, and best practices in digitization and apply relevant insights to drive innovation in the clinical supply chain.

• Help to influence the overall industry for best practices for clinical supply digitization and system integration through established industry connections, leadership positions in industry associations and / or participation at external forums.

Education Requirement:

• B.S., M.S. in an appropriate science or computer science, engineering, or business discipline

Required Experience and Skills:

• Minimum of ten (10) years’ experience in the Pharmaceutical or equivalent industry.

• Strong knowledge of digital technologies, data analytics, system integration, and emerging trends in digitalization in the healthcare or pharmaceutical industry.

• Proven experience in developing and implementing digital strategies in the healthcare or pharmaceutical industry.

• Knowledge of regulatory requirements and industry standards related to digital solutions and data in the healthcare or pharmaceutical industry.

• Demonstrated ability to lead teams in a matrix organization to achieve objectives, including collaboration, influence without authority and a strong commitment to diversity, inclusion and employee development.

• Excellent communication and presentation skills with the ability to effectively collaborate with cross-functional and cross-divisional teams and stakeholders at all levels.

• Ability to prioritize and manage multiple projects simultaneously, ensuring timely delivery and meeting business objectives.

Preferred Skills:

• Previous background directly related to manufacturing, quality assurance, quality systems, quality management systems or other GMP activities.

• Highly organized with effective project management skills and a track record of successfully leading and delivering IT projects.

• Effective negotiation and problem-solving skills.

NOTICE FOR INTERNAL APPLICANTS

In accordance with 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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Contingent Workers apply

US and Puerto Rico Residents Only:

if you need an accommodation during the application or hiring process.

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, generally Tuesday, Wednesday and either Monday or 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 aagreement (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”.

Expected salary range:

$164,800.00 - $259,400.00

1st - Day

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe 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.