Director, Quality Product Strategy (Small Molecule)

MSD•Rahway, NJ

4d•Hybrid

About The Position

The Director, Quality Product Strategy (Small Molecule) supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network. Ensures development and execution of a robust quality strategy for products supporting launch of the pipeline and/or uninterrupted supply of commercial products. Scope of responsibilities includes value chain management team (VCMT) member, franchise support of late stage pipeline Quality activities as well as inline quality related issues, sponsored project support and strategic network changes (e.g. expansion and supply chain robustness) for our inline portfolio, coordination with the Development and Commercialization Team (DCT) and Quality Working Group Leader.

Requirements

Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics with minimum of twelve (12) years of experience including quality oversight roles including technical elements or technical operations roles.
Minimum of 2 years direct experience with supply chain strategy or technical elements (e.g. change controls, investigations, process documentation (e.g. protocols, CPV, etc.), preferably with small molecule products.
Demonstrated skills for external facing communications in written and verbal form.
Demonstrated success leading multi-functional teams driving continuous improvement and execution of strategic actions across a network (i.e. multiple groups/sites/functions).
Active Pharmaceutical Ingredients (API)
Collaboration
Drug Product Manufacturing
Packaging
Pharmaceutical Drugs
Pharmaceutical Products
Product Quality
Product Quality Assurance
Quality Oversight
Small Molecule Drug Development
Small Molecule Drugs
Small Molecules

Nice To Haves

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.
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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.
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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, 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”.
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.

Responsibilities

Leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils.
Act as a quality designee for global product quality as needed.
Ensures prioritization, progress, and escalation, as appropriate, of quality related strategic goals (including strategy, efficiency and compliance related items) through periodic reviews and dashboard across products and manufacturing/testing sites across the network.
Lead and/or participate in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division.
Review and approve, as appropriate, franchise level documentation including but not limited to: Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise level protocols/reports, filing/license submissions, franchise level regulatory observation responses, RTQs, franchise level change control, site and multi-site investigations, where appropriate.
Leads/coordinates Quality Working Group meeting for the franchise, where applicable and serves as the Quality Representative to DCT/VCMT and associated working groups, where applicable.
Collaborate with Quality leads to resolve supply chain quality issues.
Collaborates with QMS Chapter leads and document owners to define, refine and standardize quality requirements.
Identifies any gaps in QMS requirements that are critical to ensure consistent interpretation of regulations as it relates to products to drive standardization and continuous improvement to QMS documents.
Track metrics (change control, complaint, etc.) for the franchise.
Evaluate the franchise's Annual Product Review for supply chain trends and escalate risks as necessary.
Actively participate and escalate issues/risk to the Quality sponsors and via IRM as required and identify need for and support development of Analytical Siting decisions.
Monitor and mitigate franchise Quality risks.
Participate in inspections as required and champion Permanent Inspection Readiness (PIR) for the product program.

Benefits

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 .

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