AddressJob Description
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
Apply technical / quality expertise to help teams remove obstacles, overcome technical challenges, and make impactful clinical disposition decisions
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:
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 others
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
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.
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.
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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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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 - $259,400.00Available 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.
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
1st - DayValid Driving License:
YesHazardous Material(s):
N/ARequisition ID:R288614
PDN-9bcb5ee4-00cf-463d-9880-d3dfb3e25bd0
