Job Information
Merck Director, New Modalities - Manufacturing Division - Quality in North Wales, Pennsylvania
Job 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 speed-to-market 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 fit-for-purpose QMS, ensuring end-to 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 early-stage 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 fit-for-purpose 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.
Stay ahead of current GMP requirements and industry trends as described in worldwide regulations and industry standards, and trend reporting. Maintain a subject matter expert level of knowledge related to these specialized areas of expertise.
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
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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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 Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
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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, 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 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”.
Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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.
Expected salary range:
$164,800.00 - $259,400.00
Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here (https://www.benefitsatmerck.com/) .
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:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Requisition ID: R290047