Job Description

　　Position Overview: Basic Functions & Responsibilities:

　　The Director, Biologics/Vaccine Development Quality (BVDQ), Global Development Quality Operations is responsible for technical, operational and strategic quality oversight of the large molecule (biologics and vaccines) pipeline, specifically drug substance GMP clinical manufacturing and process development as well as, analytical development, testing, and release. This position is responsible for managing a team of professionals who provide quality oversight to large molecule drug substance activities and who serve as DCT quality leads for pipeline programs. This position will be responsible for collaborating with our Research & Development Division and our Manufacturing Division stakeholders to deliver on program milestones and to support clinical manufacturing facility deliverables while ensuring a robust compliance posture is maintained. This role will coach and guide teams through complex technical investigations and be responsible for driving quality operations excellence.

　　Primary Activities:

　　The position involves close collaboration with key stakeholders and other Quality groups to execute against large molecule deliverables. This position is expected to independently perform the following:

　　Execute on the BVDQ quality oversight operating model for large molecule drug substance and support complex, high impact situations ranging from acceleration of pipeline programs to business development acquisitions & integrations.Review critical documents and support teams in making clinical supply disposition decisionsLead the development of and drive the execution of quality strategies and continuous improvement initiatives in line with business drivers and priorities.Provide close support of our Company's DCTs (Development & Commercialization Teams) to deliver on pipeline program milestones and clinical supply demandInteract cross-functionally and cross-divisionally with stakeholders and leaders on quality/regulatory matters and strategic initiatives.Support due diligence of business development opportunities and support acquisitions & integrationsMaintain an external presence through participation in industry consortiums and meetings external to our CompanyApply technical / quality expertise to remove obstacles and barriers facing teams.Coach, mentor and develop talent in alignment with employee development plans and business priorities

　　Skills:

　　Primary skills include but are not limited to:

　　Strong scientific/technical expertise in the clinical development space, coupled with the ability to interact with and influence subject matter experts and leaders.Strong compliance knowledge and understanding of health authority regulations, and interpretation and application of GMPs within an R&D environment (i.e., apply the GMP Continuum).Possess and apply large molecule drug substance technical knowledge; demonstrated ability to share knowledge and upskill othersAbility to lead & support complex cross-functional initiatives.Strategic leadership, including experience with strategy deployment and change execution managementDemonstrate experience with quality risk management.Strong cross-functional teamwork, collaboration, and negotiation skills.Demonstrated ability to communicate (oral and written) effectively with diverse individuals / groups.Financial stewardship and experience managing a budget.Significant experience serving as a mentor / people manager

　　Education/Experience:

　　Bachelor Degree in Engineering, Biology, Chemistry or related field.A minimum of 10+ years of relevant experience working within the biologics and vaccines / pharmaceutical industry or advanced Degree with 8+ years of relevant experience.

　　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.

　　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

　　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.

　　We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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　　We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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, 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".

　　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:

　　Yes

　　Hazardous Material(s):

　　N/A

　　Requisition ID:R272136