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Associate Director, Quality Control

3 months ago

Durham, North Carolina, United States Merck Full time

Job 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 committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Our Company in the United States and Canada is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our Company has codified its legacy for over a century. Ethical integrity, forward momentum, and an inspiring mission back our success to achieve new milestones in global healthcare.

Our Company's Manufacturing Division, is a team of energetic colleagues who are dedicated to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that is committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

Accountable for developing, implementing, and overseeing the daily operations of a Quality Operations Laboratory group and ensuring that the laboratory is maintained in a state of GMP compliance, that all documentation is generated in accordance with GMP, and that all reported results are accurate.

Primary Responsibilities

  • Provides direction to individual contributors (professional employees) and managers.
  • Contributes to the performance and results of the department.
  • Adapts departmental plans and priorities to address resource and operational challenges.
  • Implements plans and priorities based on department, site, and divisional objectives.
  • Accountable for oversight and compliance of method validation and transfers including approval of validation schedules, project plans, master plans, validation protocols and reports.
  • Provides technical guidance to employees, colleagues, or clients.
  • Anticipates and interprets client and/or customer needs to identify solutions.
  • Demonstrate excellent people skills including the ability to effectively partner with staff from other departments.
  • Demonstrate excellent written and verbal communication skills.
  • Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests.
  • Ability to work objectively and as a member of the site Quality Leadership team.
  • Ability to invest time, as required, expediting, or completing assignments or projects. This shall include working non-standard hours such as evenings and weekends, as necessary.
  • Demonstrate strong spreadsheet, word processing and database skills necessary to process and present technical data in a clear and concise manner.
  • Demonstrate advanced computational skills including algebra, trigonometry, and basic statistics.
  • Applies management skills to align staff activities with department objectives.
  • Identifies and resolves technical and operational problems; partners with peers to resolve problems that cross into inter-related units.
  • Makes decisions – guided by policies and procedures – that impact the unit's ability to meet performance objectives.
  • Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.
  • Forecasts resource needs; manages allocated budget.
  • May design studies for assay validation
  • Attend relevant seminars and ongoing training.
  • Represent department during FDA and other Regulatory Agency Inspections

Minimum Education Required:

Bachelor's degree in biology, Chemistry, Biochemistry, or other relevant Life Science discipline

Required experience and skills:

  • Minimum eight years of work experience in a pharmaceutical/biotechnology environment
  • Experience supervising technical staff in a Quality Control and/or cGMP environment.
  • Strong knowledge of Data Integrity principles
  • Ability to plan, initiate, implement, and oversee department activities with a focus upon ensuring attainment of department objectives.
  • Performance management and career development for subordinate supervisory and/or technical staff
  • Developing and implementing operational, policy and procedural directives for area(s) of assignment
  • Reviewing and approving recommendations and/or diagnostic QC data presented by subordinate(s) as appropriate.
  • Developing and administering budgets, schedules, and performance requirements for department, including accountability for results in terms of costs, methods, and employees
  • Developing departmental strategic staffing plans and justifications for headcount and capital equipment requests
  • Partnering with senior and executive management in the decision-making process for capital equipment expenditures and the acquisition of modern technologies
  • Ability to utilize continuous improvement to accomplish department goals in the most cost effective and productive manner while maintaining high quality standards.
  • Ability to function as project leader to coordinate activities between divisions and provide scientific direction.

Preferred experience and skills:

  • Familiarity with scientific disciplines outside of primary areas of expertise
  • Familiarity with microbiological methodology and techniques
  • Previous experience supporting a sterile manufacturing facility.

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.

VETJOBS

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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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

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

BSL 2

Job Posting End Date:

07/27/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Job Posting End Date:07/27/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R305864