Job Description

　　The Associate Director within Quality is responsible for providing Quality direction and oversight to the West Point (WP) Site in the management of those areas assigned, such as Training, Documentation (including Standard Operating Procedures and Master Batch Records), Annual Product Review, Change Control, Inspection Management, Quality Management Systems, and Risk Management to maintain compliance with Regulatory requirements. The individual is an Advocate and Leader for the development, execution and deployment of WP Site and priorities. The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas.

　　The Associate Director, Quality will have direct Quality oversight of the team supporting shopfloor activities as part of a Quality IPT (Integrated Production Team) operating model. With guidance from the IPT Quality Lead, the Associate Director ensures product/process quality to facilitate review of batch documentation and supporting a state of Permanent Inspection Readiness (PIR). The Associate Director also completes approval of documents associated with deviation management, change control, validation and external customer complaints, and provides Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, effective investigation of deviations and support for change controls. The Associate Director will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance. Job functions are achieved primarily on the production shop floor and in a team environment.

　　Key Responsibilities

　　Management of the team performing batch record review, documentation review, and shopfloor oversight. Sets prioritization for this team and manages daily workflow.

　　Partners with Planning, Operations and Technology organizations to ensure batch documentation is complete by appropriate due dates.

　　Completes approvals of Deviation Management, Change Control, Validation and External Customer Complaint documentation.

　　Leads cross-functional continuous improvement initiatives for quality-related functions.

　　Supports Regulatory inspections. Assists in identifying and preparing documentation for review during a regulatory inspection. Serves as a subject matter expert and presents documentation to regulatory inspectors.

　　Provides coaching and mentoring of manufacturing supervisors and operators.

　　Conducts and completes Quality review/approval of new and updated SOPs and Controlled Job Aids.

　　Assists with training of incoming personnel and ensures compliance with departmental procedures.

　　Actively participates in the Tier process and uses this forum to escalate concerns and best practices.

　　Partners with IPT members in the identification and implementation of continuous improvement initiatives and action plans.

　　Education Minimum Requirement and Experience:

　　Bachelor’s Degree (BA/BS) in Science, Engineering, or another technical field with five (5) years of experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain; OR

　　Master’s Degree (MA/MS) in Science, Engineering, or another technical field with three (3) years of experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain

　　Required Experience and Skills:

　　Experience of interacting with site, divisional, or regulatory audits.

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

　　Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

　　Preferred Experience and Skills:

　　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. MPS experience - LSS Green Belt certification or equivalent experience.

　　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.

　　Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

　　Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

　　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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

　　EEOC GINA Supplement​

　　Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

　　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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

　　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:

　　Hybrid

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　n/a

　　Requisition ID: R278133