Job Description
IPT Quality Lead
M2
The Associate Director within Quality is responsible for providing Quality direction and oversight to one of our sites in the quality systems, such as Training, Documentation (including Standard Operating Procedures and Master Batch Records), Annual Product Review, Change Control, Inspection Management, Quality Management System, and Risk Management to maintain compliance with Regulatory requirements.
The individual is an Advocate and Leader for the development, execution and deployment of the site and our priorities. The Associate Director drives quality improvement activities and ensures alignment across the organization in the execution of their assigned areas. The Associate Director is responsible for Quality oversight of vaccine formulation and filling operations as well as the associated Quality Systems. The qualified candidate ensures compliance to Divisional, Company, and Site standards and procedures. The incumbent manages a team of Quality Specialists, responsible for elevating our compliance posture. This role partners with the Operations and Technical Operations Leaders 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 analytical and scientific acumen to assist with troubleshooting of processes and systems. Excellent leadership capabilities, including cross-functional collaboration, written and verbal communication skills, structured problem solving, disciplined decision-making, and talent management are required. The incumbent will actively participate in external regulatory inspections.
Primary activities include but are not limited to:
Directly leads activities in the execution of quality system functions relating to GMP compliance; additionally, champions multi-department teams regarding various compliance initiatives and assessments.
Coordinates and directs a team of multi-disciplined professionals in areas of process and systems as they relate to support and enhancements of the quality system(s)
Ensure personnel operate within established policies/procedures of our Company and in compliance with cGMPs and all applicable government regulations. Responsible for hiring and ensuring personnel are trained and performing per expectations.
Manage and coach the Quality team (direct and indirect reports) to deliver strong results while developing individual and team capabilities.
Ensure that all team members operate safely and comply with established safety and environmental policies and procedures (Corporate, Site, and Governmental)
Serve on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums as well as strategic initiatives.
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 identify and implement continuous improvement actions to solve problems and implementation corrective and preventative including but not limited to reducing deviations, reducing lead-time, improving safety and eliminate waste, while maintaining compliance.
Review and approve deviations, corrective / preventative actions, commitments, change requests, and other Quality documents.
Minimum Education Requirements and Experience:
Bachelor's Degree in Science, Engineering, or another technical 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 in Science, Engineering, or another technical field with six (6) years' experience in a functional area, such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain
Required Experience and Skills:
Minimum two (2) concurrent years' experience managing direct reports.
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.
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.
Aseptic/sterile processing experience
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/task/1422$6687.htmld)
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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
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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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
N/A
Job Posting End Date:
10/7/2024
*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: 10/07/2024
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: R315384
