Director, Quality Assurance

2 weeks ago

West Point, United States Merck Sharp & Dohme Full time

We are seeking an exceptional scientific leader for the role of Director, Quality Assurance in the Biologics/Vaccine Development Quality group, located in West Point, PA.

Biologics/Vaccine Development Quality (BVDQ) within Global Development Quality is responsible for technical, operational and strategic quality oversight of a growing and fast moving large molecule pipeline. BVDQ is specifically focused on quality oversight for large molecule drug substance process & analytical development, GMP clinical manufacturing, and the testing & release of clinical supplies. This position is responsible for managing a team of professionals in BVDQ who support large molecule drug substance activities and who serve as cross-functional Quality leads for pipeline programs. The leader in this role will be responsible for collaborating with our Research Labs and our Manufacturing stakeholders to achieve industry leading research & development and clinical supply manufacturing capabilities to deliver on pipeline milestones and to ensure uninterrupted supply of compliant clinical material. This role will coach and guide teams through complex technical issues and drive on quality operations excellence initiatives. This role will also develop talent in accordance with employee development plans and business priorities.

**Primary Activities**:
Responsibilities include but are not limited to:

- Lead a team of professionals to execute on quality oversight deliverables for large molecule drug substance process & analytical development, GMP clinical supply manufacturing, and testing & release of clinical material
- Review and approve critical documents
- Represent Quality on cross-functional integrated CMC teams for high priority pipeline programs and coach team members who serve as Quality leads
- Collaborate with peer leaders in Process R&D, Analytical R&D, and Clinical Manufacturing Operations to drive on strategic initiatives and continuous improvement opportunities
- Contribute to establishment and sustainability of a safety first, compliance always culture
- Perform due diligence assessment of critical business development opportunities and support acquisitions & integrations
- Maintain an external presence through participation in industry conferences and consortiums
- Coach, mentor and develop talent while serving as a people manager

**Skills**:
Primary skills include but are not limited to:

- Ability to lead & support complex cross-functional initiatives.
- Strategic leadership, including experience with strategy deployment and change execution management
- Demonstrate 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**

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

**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.**

**US and Puerto Rico Residents Only**:
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration fo

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