Associate Director, Quality Control

Job Description

The Associate Director of Laboratory Technical Services (LTS) is responsible for providing direction and oversight to a team of specialists proving technical support to the microbiology laboratories. This team is responsible for investigation support, problem solving, change control, organism assessments and microbiological trending. LTS also manages a large portfolio of projects for the laboratory that were initiated for continuous improvement and strategic initiatives.

Primary activities include, but are not limited to:

• Responsible for ensuring compliance in accordance with cGMPs, regulations and our company's guidelines, policies, and procedures.
• Advocate for maintaining a safe work environment.
• Provides program management leadership for projects aimed at elevating the compliance and performance of the laboratories.
• Lead key projects for the site aimed at elevating the compliance and performance of analytical methods.
• As the lead, fully manage all aspects of assigned projects and run the business activities, including but not limited to: decision making, stakeholder management, issue identification and resolution, understanding of capacity and demand, participates and drives the tier process, as appropriate, and uses this forum to escalate concerns and best practices.
• Proactively partners with Laboratory Quality Assurance personnel to ensure compliance with regulations, guidelines, and procedures.
• Ensures that all process improvements and capital projects are timely, robust and in alignment with corporate goals.
• Provides microbiology support to the production departments that manufacture sterile vaccines.

Education:

• Bachelor of Science (BS) degree in life science, science discipline, or engineering with ten (10) years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations in a laboratory, manufacturing, science related, or regulated setting.
• A degree in microbiology is strongly preferred. OR Master of Science (MS) degree in life science, science discipline, or engineering with eight (8) years of experience in GMP Manufacturing environment, Pharmaceutical/Biological Quality, Operational, Technical or Regulatory function supporting manufacturing or testing operations in a laboratory, manufacturing, science related, or regulated setting.

Preferred Experience and Skills:

• Microbiology laboratory experience is strongly preferred with an in-depth working knowledge and application of GMPs/GLPs.
• Previous people management experience: ability to develop staff.
• Demonstrated facilitative leadership skills and able to lead teams to deliver results.
• Progressive and demonstrated Quality decision-making responsibility.
• Proven ability to manage multiple projects/tasks simultaneously.
• Project Management, Change Execution Management and Team Leadership experience in a Quality function.
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.
• Demonstrated self-starter with capability to develop innovative solutions to challenges.
• Proven analytical aptitude, critical thinking skills and ability to apply key concepts.
• Speaks with courage and candor.
• Strong written and verbal communication skills.
• Familiar with aseptic technique and sterile manufacturing.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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:07/29/2024

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:R303612