IPT Quality Lead

Job Description

Integrated Product Team Quality Lead

The Associate Director within the Rotavirus Bulk Integrated Product Team (IPT)-Quality is responsible for ensuring alignment to Divisional, Company, and Site policy, procedures, and guidelines for Quality Operations responsibilities within the IPT. These activities involve all Quality aspects associated with the IPT's manufacturing of drug substance and drug substance intermediate manufacturing including but not limited to, batch record review, release, deviation management, change control, shop floor audits and general compliance and release activities. The Rotavirus Bulk IPT Quality Operations Leader manages a team responsible for the release of all Rotavirus intermediates and products.

To effectively manage Quality Operations within the IPT, the IPT Leader must demonstrate excellent leadership abilities with strong technical and quality understanding of processes and leverage critical thinking and problem solving to enable quality by design output of our products. Effective collaboration, communication, decision-making, and talent management are required capabilities. The IPT Quality Operations Leader also participates in regulatory inspections and is a member of the IPT Leadership Team and the Rota E2E Quality Leadership Team.

This role partners with the Operations and Technical Operations Leaders within the Rotavirus Bulk IPT to ensure that products are manufactured and tested according to approved processes and comply with all applicable regulatory and internal requirements. The qualified candidate must demonstrate strong excellent management capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, driving quality improvement activities, disciplined decision-making, and talent management are required. The incumbent will actively participate in external regulatory inspections.

Key Functions:

• Ensure personnel operate within established policies/procedures of our Company and in compliance

• Manage the IPT quality team which are accountable for providing day-to-day assurance that the facilities, equipment, personnel, methods, records, controls, validations, processes, and practices are in conformance with all applicable regulations

• Manage and coach the Quality team (direct and indirect reports) to deliver strong results while developing individual and team capabilities

• Partner with Operations and Technology IPT Leads to provide direction and prioritization in projects and initiatives within the E2E

• Assist in process improvement activities and workload management for the IPT quality team

• Ensure that all team members operate in a safe and efficient manner and in compliance with our Company Manufacturing Division (MD) QO Safety and Health Policy

• Serve on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums

• Acquire and maintain technical process knowledge relevant to operations and testing. Ensure that documentation and products manufactured comply with all applicable standards and procedures, and governing regulations

• Proactively partner to implement continuous improvement actions to reduce deviations, reduce lead-time, and eliminate waste, while maintaining compliance

• Review and approve deviations, corrective / preventative actions, commitments, change requests, and other Quality documents

Minimum Education and Experience Requirement:

• Bachelor’s Degree of Science (BS) in Science, Engineering, or related field with eight (8) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain; OR

• Master’s Degree of Science (MS) in Science, Engineering, or related field with six (6) years’ experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain

Required Skills and Experience:

• Minimum two (2) concurrent years’ experience managing direct reports

• Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.

• Demonstrated leadership and management experience working with cross-functional teams on objectives to deliver on Key Performance Indicators, meet significant project milestones, and lead an organization to meet priorities for the year

• Effective at continuous improvement, lean, six sigma implementation

• Demonstrated experience with quality systems such as deviation management, quality risk management, and change control

• Demonstrated proven leadership experience with domestic and international regulatory agencies in a compliance/inspection setting

Preferred Skills and Experience:

• Minimum of three (3) years’ experience in a supervisory/management capacity

• Vaccine manufacturing experience

• 8-step problem solving trained and practicing

• Compliance - Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to author, review and/or approve compliance documents, as per procedures or need. Has experience and ability to achieve compliance goals, through a risk-based approach has a deep understanding of GMP and EHS compliance and compliance risk.

• Working Across Boundaries – Must possess excellent interpersonal, communication, collaboration, negotiation to work outside boundaries as a norm

• Business Outcomes /Drive Results – Ability to use deep knowledge and expertise in production operations to drive results and business outcomes

• Demonstrated experience of interacting with site, divisional or regulatory audits

• Demonstrated ability to create an engaged workforce using Inclusion as the How

• Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion.

• Demonstrated success with Talent Management including leading and mentoring

• Proven ability to manage multiple projects simultaneously.

• Applies knowledge of internal/external business challenges to improve products, processes, or services.

• Solves complex problems; takes a new perspective using existing solutions.

• Works independently, receives minimal guidance.

• Demonstrated self-starter with capability to develop innovative solutions to challenges.

• Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein 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.

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”.

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):

Requisition ID:R284765