Associate Director, Quality Assurance- Validation- Hybrid

Job Description

The Associate Director Quality Assurance, Facilities, Validation & Automation will provide Quality Assurance oversight and support to Good Manufacturing Practice (GMP) facilities, equipment, and laboratories within the Research and Development Division development space.

This includes both existing facilities, equipment, and laboratories as well as those associated with new capital investments projects. The role will also work to ensure new facility design, changes, and improvements adhere to international Good Manufacturing Practice (GMP) requirements and applicable guidance for the production of clinical Good Manufacturing Practice (GMP) drug substance, drug product and packaged goods across all modalities to ensure worldwide clinical supplies are supported and suitable for use.

The primary responsibility will be at the Rahway, NJ site though the expectation is that support is provided as necessary to other sites within the clinical network (e.g., West Point, PA site). The role is reports to the Director of Facilities and Validation.

Primary Responsibilities

• Responsible for providing quality assurance support and oversight for commissioning/qualification of the facilities, equipment and instruments in the manufacturing facility and the associated laboratories.
• Responsible for providing quality oversight for automation systems for new facilities and upgrades to the existing facilities. Automation systems include systems such as Delta V, BAS, BMS & SCADA.
• Responsible for quality oversight cleaning and thermal validation.
• Responsible for the review and approval of Standard Operating Procedures (SOPs).
• Provide Quality support for Environmental Area and Utility Performance Qualification Plans, Protocols and Reports.
• Quality ownership for new capital projects which can include new facility associated utilities and equipment.
• Leading routine process support and improvement activities.
• Providing Quality guidance for daily production support, projects, deviations, and changes.
• Provide Quality support in maintaining facilities and equipment systems in a state of permanent inspection readiness.
• Serving as Quality Subject Matter Expert during regulatory inspections and audits.

Education Minimum Requirements

• Bachelor Degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Chemistry, Biochemistry or a related field with ten (10) years of relevant experience. Masters Degree preferred.

Experience and Skills

Critical Skills

• Experience in regulated or Good Manufacturing Practice (GMP) manufacturing and/or Quality support of manufacturing operations
• Strong and demonstrated experience in Facility, Equipment, Instrument, and computer system validation.
• Experience with aseptic processing operations such as bulk production, formulation, vial filling, and lyophilization, and supporting clean utilities.
• Familiarity with change control systems and Quality assessment of change in a current Good Manufacturing Practice (cGMP) production environment
• Experience with deviation management and associated systems
• Experience with sterile processing and sterility assurance practices and guidelines
• Strong experience with QRM (Quality Risk Management)
• Strong working knowledge of SDLC, GAMP and automation systems
• Demonstrated project management skills.

Critical Behavioral and Leadership Competencies

• Cross-functional collaboration
• Focus on delivering customer value.
• Personal Attributes and Characteristics
• Demonstrated interest working in a diverse and constantly changing environment.
• Detail oriented and organized.

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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, Monday - 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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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.

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• 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:R337401