Associate Director, Quality Operations

Job Description

The Associate Director drives quality improvement activities and ensures alignment across the execution of their assigned areas and is accountable for the development and maintenance of Quality Systems in particular the execution of wash, assembly, and sterilization of components in accordance with cGMPs, international regulations and our Company Quality Management systems, policies, and procedures.

The successful candidate manages a team responsible for the quality oversight of the Sterile Supply departments that support downstream customer needs for vaccine manufacturing and will guide their team in quality decision making and support the development of personnel through effective coaching and feedback and by modeling inclusive behaviors.

To effectively manage Quality Operations within the IPT, the Associate Director must demonstrate excellent leadership abilities with strong quality decision making, problem solving, and collaboration with their Operations and Technology leads. IPT Quality Operations Leader also participates in regulatory inspections and is a member of the IPT Leadership Teams and the E2E CSS&IM Quality Leadership Team.

Additional Responsibilities

• Maintains strong quality management systems to actively ensure compliance while striving to optimize Quality Operations
• Actively participates in the Tier process, as appropriate, and uses this forum to escalate concerns and best practices
• Serves as an Ad Hoc member of the Site Quality Council
• Responsible for the Quality oversight and classification/approval of investigative events
• Provides guidance to Senior Quality Specialists conducting reviews/approvals of investigative events
• Provide input on recommended CAPAs, as appropriate
• Completes review and approval for CAPAs, QCTS commitments, change requests, and investigative protocols and final reports
• Initiates and completes review and approval of IQ/OQ/PQ documents for assigned areas of responsibility
• Provides Quality consult to Quality Specialists performing monthly internal audits of production areas
• Reviews and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
• Provides coaching and guidance to new personnel
• Actively support to Regulatory Agency Inspections
• Proactively partners with Operations and Technology personnel to ensure that all key performance metrics and process improvements are timely, robust and in alignment with corporate goals

Education Minimum Requirement:

• Bachelor's degree in Life Sciences or Engineering discipline, with eight (8) years minimum experience in Pharmaceutical Quality, Technology or Operations, Regulatory, or related experience with progressive responsibility

Required Experience and Skills:

• Quality Systems knowledge
• Project Management, Change Execution Management and Team Leadership experience
• Interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
• Independent and Collaborative with capability to develop innovative solutions to opportunities
• Facilitate management skills and able to lead cross-functional project teams to deliver results
• Proven quality aptitude, critical thinking skills, and ability to make critical decisions
• Speaks with courage and candor
• Principled written and verbal communication skills
• In-depth working knowledge and application of GMPs
• Proven ability to manage multiple projects simultaneously

Preferred Experience and Skills:

• Minimum three years in a supervisory/management capacity
• Previous experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing
• Demonstrated proven leadership experience with domestic and international regulatory agencies in a compliance/inspection setting
• Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc.
• Deviation Management experience
• Technical understanding of Biologics, vaccines, and small molecules business
• Direct floor manufacturing
• Cleaning and Sterile Validation 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.

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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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”.

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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:

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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:05/24/2024

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:R295652