Director, New Modalities - North Wales, United States - Merck Sharp & Dohme

Merck Sharp & Dohme

Verified Company

North Wales, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Description:

Reporting to the AVP of New Modalities our Manufacturing Division Quality, this leader is responsible for supporting the implementation of a unique quality oversight model necessary to facilitate agility and speed-to-market while ensuring sustained compliant supply of specialty New Modalities pipeline products to global markets, to serve our patients.

This leader will support the implementation, including change management actions, of the new organization to support a fit-for-purpose quality management system and ensure strategic quality oversight of new modalities products manufactured in the network and at external partner sites.

The leader will interact with our cross-divisional/functional teams from development through commercialization to ensure implementation of the designed quality oversight model.

Activities will include implementation of required Quality Management System (QMS) elements, procedures, and systems to ensure quality and regulatory compliance with Current Good Manufacturing Practices (CGMPs), other worldwide regulations and requirements.

Primary Responsibilities**:

Provide Quality leadership to our partnership in support of the V940 Individualized Neoantigen Therapy (INT) program.
Provide Quality leadership as part of the new Quality Platform to ensure end to end quality oversight necessary to facilitate agility and speedtomarket while sustaining compliant supply of New Modalities pipeline products to global markets.
Evaluate current and partner Quality Management Systems for seamless integration and realize synergies where available while ensuring compliance to GMP requirements. Ensure alignment to corporate policies as well as other divisional policies related to management of product quality.
Implement a fitforpurpose QMS, ensuring endto end quality oversight of New Modalities products manufactured at our company and external partner sites. Partner with our Manufacturing Division QMS team for QMS updates as needed.
Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support of earlystage development to commercialization of New Modalities products.
Work in partnership across the organization to understand the unique requirements for the new modality products and ensure that these requirements are addressed via fitforpurpose quality management oversight.
Evaluate external partner Quality and compliance robustness and identify Quality risks. Work with internal colleagues and external partners to remediate risks as appropriate. Ensure that facilities/processes are compliant and support approval of new modality regulatory filings.

- our Technical CMC teams for end-to-end Quality oversight/support of New Modalities products.

Support development of and report quality metrics measuring operational effectiveness to appropriate governance forums.
Ensure continuous improvement to New Modalities QMS to maintain GMP and Regulatory compliance.
Provide guidance and coaching to colleagues on New Modalities quality oversight requirements and Health Authority GMP expectations.

Required:

Bachelor's degree in Life Science Field, Engineering field or a related relevant discipline.
Minimum of ten (10) years' experience within the pharmaceutical industry.

Required Leadership and Technical Skills:

People change management experience
Technical experience with vaccines, biologics, and / or cell gene therapy products
Technical Operations, Quality operations and/or compliance experience
Demonstrated effective leadership, communication, interpersonal and negotiating skills, in particular with cross functional partners
Ability to learn and understand technical aspects of new processes to ensure robust Quality oversight

Preferred:

Experience in both Quality Assurance and Quality control
Experience in external manufacturing / external quality assurance or alliance management
Experienced in interacting with regulators
Advanced degree in Life Sciences field, Engineering field or a related relevant discipline

NOTICE FOR INTERNAL APPLICANTS

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.

GRACSJOBS

EBRG
**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 stakeholder