Associate Director, Quality Environmental Monitoring

Job Description

We are seeking a Growth and Improvement minded Quality Environmental MonitoringAssociate Director that can help drive our Strategic Operating Priorities.

 

·       Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

·       Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

·       Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

·       Diverse Talent | We provide an inclusive and welcoming environment with supporting leadership behaviors because having a high performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world.

·       Values and Standards | Our Steadfast Dedication to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Strategic Summary

Our ability to excel depends on the integrity, knowledge, imagination, skill, and diversity of people like you. To this end, we strive to create an environment of mutual respect and teamwork. As part of our global team, you will have the opportunity to partner with talented and dedicated colleagues while developing and expanding your career.

 

The Associate Director, Quality Environmental Monitoring at our Company's Facility will lead laboratory operations for the compliant sampling of the GMP manufacturing and laboratory areas, KPI reporting and facilitating regulatory audits.  The individual in this role will provide guidance, cross-functional development, and technical expertise to the Environmental Monitoring team which is comprised of personnel in various stages of their career development.  

 

The Associate Director must be an advocate for maintaining a safe work environment and will be accountable for meeting and driving projects and change management ensuring commercial needs are met.  This includes the goals of schedule adherence and right-first-time execution of testing and will also include project management for effective startup within their areas of responsibility for new products to the facility. The Associate Director will be expected to lead the Environmental Monitoring team by providing guidance and strong partnership between Quality Operations, Laboratory Quality Assurance, and Manufacturing Operations.

 

The Associate Director will support key projects for Quality Operations aimed at elevating the compliance, process and method robustness, and performance of the areas within their responsibility.  As the direct lead for the area of responsibility assigned, the individual is expected to 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, comprehension of capacity and demand, participation and driving the tier process, 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 project work, process improvements and capital projects are timely, robust and in alignment with corporate goals. 

 

Key Functions

• Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Reports to the Quality Operations Laboratory Director, will manage approximately 20 direct reports and carry out supervisory responsibilities in accordance with our Company’s policies and guidelines.
• Environmental testing of GMP areas, project facility performance qualifications, and subsequent testing of those samples
• Contacting IPT areas when samples/tests discrepancies are observed for timely correction.
• Coordinates with Quality Control to ensure testing is completed for samples taken.
• Coordinates with other departments (such as Operations, Quality Assurance, Validation, and Technology) to gather all required information and documentation in relation to process improvement, implementation and/or investigations.
• Support audits and inspections to provide data and information on request.
• Comprehends and implements safety procedures and Good Manufacturing Practices
• Identifying process improvements and coordinating implementation of new processes in their functional area
• Maintains up to date familiarity with all applicable corporate and regulatory guidelines with respect to their functional area.
• Ensure test data is accurate, GMP compliant and all work is completed Right-First Time
• Routinely participates in laboratory related activities such as second person review, validation, qualification, report writing, deviation investigations, change control, training, and others.
• Work independently in an open team environment and have strong problem solving and communication skills. 
• Interacting with and understanding various data acquisition/management software, SAP, Global Laboratory Information Management Systems (GLIMS), and Trackwise
• Works with colleagues to continuously improve laboratory performance around safety, GMP compliance, data integrity, turnaround times, and cost.

 

Minimum Education and Experience Requirement:

• Bachelor’s Degree (BA/BS) in Chemical Engineering, Biochemical Engineering, Biological Systems Engineering, Biology, Biochemistry, Chemistry or related Life Science or Engineering Discipline with eight (8) years’ experience demonstrating increasing responsibilities in pharmaceutical industry supporting a GMP manufacturing facility experience. OR
• Master’s Degree (MA/MS) in in Chemical Engineering, Biochemical Engineering, Biological Systems Engineering, Biology, Biochemistry, Chemistry or related Life Science or Engineering Discipline with six (6) years’ experience demonstrating increasing responsibilities in pharmaceutical industry supporting a GMP manufacturing facility experience.

 

Required Experience and Skills:

• Must have leadership and strong partnership skills | Work with team members on and off-site.
• Demonstrated knowledge of Quality Systems including change control, deviations, CAPAs and training.
• Previous SAP batch disposition experience.
• Experience in Lean Six Sigma methodology. 

Preferred Experience and Skills:

• Familiarity with batch disposition of raw materials and general components associated with vaccine drug substance and drug product.
• Demonstrated strong customer service and execution of action items identified by stakeholders.
• Effectively communicates under pressure and possess strong interpersonal skills.
• Impeccable team skills, including ability to coach/develop work teams, provide training, motivate/empower others, and resolve conflict.

 

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

Current Contingent Workers apply HERE

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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:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Requisition ID:R287848