Associate Director, Manufacturing Technical Quality

Job Description

The Associate Director, Quality Technical, is responsible for leading a team that supports deviation management, change control, site qualification/validation, equipment qualification, and technical support quality for sterile manufacturing of vaccines. The ideal candidate would have prior knowledge, thorough understanding of sterile manufacturing and background working with grade A,B, C and D area including isolator operation.

GENERAL PROFILE:

• Manages individual contributors (professional employees) and / or supervisors

• Contributes to the performance and results of a department

• Adapts departmental plans and priorities to address resource and operational challenges

• Decisions are guided by policies, procedures and business plan; receives guidance from manager

• Provides technical guidance to employees, colleagues or clients

• Anticipates and interprets client and / or customer needs to identify solutions

BUSINESS EXPERTISE:

• Applies management skills to align staff activities with department objectives

FUNCTIONAL EXPERTISE:

Specific to Technical Support, the Associate Director will be responsible for comprehensive management of all activities required to successfully support the site product release program to include the following:

• Lead the team and others by providing direction and guidance

• Deviation management, Review and approve Quality Notifications (QNs)

• Author, review, and approve SOPs

• Take on project management opportunities, by leading and participating in process improvement, learning events, or business support initiatives, as guided or approved by Quality management

• Train employees on new or revised processes or procedures

• Determine staffing needs and hire to meet those demands

• Review and approve Change controls, Quality Risk Management

• Serve as the Subject Matter Expert for all technical support quality related to graded area and aseptic processing

• Serve as SME during regulatory inspection

• Review and approve Operation, Technology, or Automation protocols

• Participation in MPS

• Other duties as requested by Management

PROBLEM SOLVING:

• Identifies and resolves technical and operational problems; collaborates with peers to resolve problems that cross into inter-related units

IMPACT:

Influence

• Explains difficult concepts and persuades others to adopt point of view.

• Communicates information, asks questions and checks for understanding

Accountability

• Accountable for the performance of work group

Decision Making

• Makes decisions – guided by policies and procedures – that impact the unit’s ability to meet performance objectives

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

STRATEGIC PLANNING:

• Adapts and implements departmental plans and priorities based on division scorecard to address local business, service and operational challenges

• Must have continuous improvement mindset

RESOURCE MANAGEMENT:

• Forecasts resource needs; manages allocated budget

Education Minimum Requirement:

• Bachelor’s degree of science (BS) in Science or Technology or related disciplines with eight (8 years of experience.

• Master’s degree of science (MS) in Science or Technology or related disciplines with six (6) years of experience.

Preferred Experience and Skills:

• Quality Assurance and/or cGMP experience

• Minimum of 2 years managerial experience recommended

WORKING RELATIONSHIPS:

• Reports to Quality Director

• Manages and interacts with employees within own department

• Frequent interaction with employees from other departments

• Interacts with representatives from regulatory agencies

• Interacts with external suppliers

Note:   This description is not intended to be all-inclusive or a limitation of the duties of the Job.  It is intended to describe the general nature of the job that may include other duties as assumed or assigned. 

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. VETJOBS #EBRG

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”.

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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:

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Travel Requirements:

Flexible Work Arrangements:

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