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Form of workJob Description
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Vice President (AVP), West Point Quality Operations, reports to the Vice President Vaccines Quality and provides strategic direction and leadership to the West Point Quality Operations (WPQO) organization. Directs all quality related functions at the site including Quality Control (QC) testing and release, auditing, product release, environmental monitoring, and GMP compliance for vaccines and non-sterile pharmaceutical products. Ensures that products are manufactured in compliance with all relevant regulatory guidelines and standards and facilitates innovation and continued improvement. Employs risk management based on scientific knowledge and protection of the patient.
Primary Responsibilities:
In the next 3 years, the top deliverables from the AVP, West Point Site Quality Head are:
The West Point Quality organization is ~650 people.
Education:
Required Experience and Skills:
Preferred Experience and Skills:
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
Domestic/International
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
On-Site
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Associate Vice President (AVP), West Point Quality Operations, reports to the Vice President Vaccines Quality and provides strategic direction and leadership to the West Point Quality Operations (WPQO) organization. Directs all quality related functions at the site including Quality Control (QC) testing and release, auditing, product release, environmental monitoring, and GMP compliance for vaccines and non-sterile pharmaceutical products. Ensures that products are manufactured in compliance with all relevant regulatory guidelines and standards and facilitates innovation and continued improvement. Employs risk management based on scientific knowledge and protection of the patient.
Primary Responsibilities:
- Provides direction and leadership to the quality directors of the manufacturing areas and laboratories, and quality assurance of the West Point Vaccines Manufacturing Site. Key activities include developing a strategic vision; managing headcount, profit plan and capital plans.
- Ensures that the laboratories execute testing compliant with external regulatory guidelines and internal GMP standards. This includes testing programs for raw materials, in-process materials, and finished products.
- Ensures that the departments have the resources needed to perform all Quality Assurance activities required to maintain product quality. Ensures that all products released to the market are manufactured within regulatory and internal standards.
- Assists departmental personnel in resolution of any significant Quality Assurance and Quality Control activities, including deviation investigations, customer complaint investigations, and issuance of regulatory notifications.
- Serves as a liaison with regulatory agencies during inspections. Ensures that all regulatory inspection observations are addressed in a complete and effective manner.
- Is responsible for approving all Biological Product Deviation Reports and Field Alert Reports for West Point.
- Is responsible for the effective execution of all major Human Resources (HR) processes across multiple departments and work environments ranging from team-based work units to the union-regulated settings
- Works directly with plant manager on issues ranging from tactical/ troubleshooting to strategic decisions.
- Serves on a number of management teams. Provides consultation to the VP, Vaccines Quality, on general quality issues. As needed, represents the quality function on divisional project teams
In the next 3 years, the top deliverables from the AVP, West Point Site Quality Head are:
- Compliant reliable supply of vaccines
- Introduction of new vaccine products; currently 2 are sited at West Point
- Start-up of multiple new facilities and tech transfer into the facilities
- Laboratory transformation through digitization, lean manufacturing, and modernization
- Talent management and development
The West Point Quality organization is ~650 people.
Education:
- BS in a related field (Biology, Chemistry, Engineering) is required
Required Experience and Skills:
- 15+ years of experience in quality and manufacturing operations is required.
- Incumbent must possess strong analytical and problem-solving skills, extensive knowledge of GMPs and the ability to make decisions in a constantly changing environment.
- Requires the ability to get things done through others, knowledge of foreign cultures and knowledge of labor relations practices (union and non-union).
Preferred Experience and Skills:
- Advanced degree preferred.
- Experience in site-based manufacturing and quality operations managerial roles, experience at multiple sites is preferred.
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
Learn more about your rights, including under California, Colorado and other US State Acts
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:
Domestic/International
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
On-Site
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
NA
