Associate Director, Quality Assurance

Job Description

Join us as the Quality Center of Excellence Lead at our Wilmington Biotech site, where you'll shape the future of breakthrough medicines by ensuring top-tier quality and compliance with global regulations. Lead a high-performance team, drive commissioning and validation excellence, and collaborate globally to deliver life-changing therapies right first time to patients worldwide. If you have 10+ years in Quality Assurance and a passion for innovation and leadership, this is your opportunity to make a global impact.

JOB DESCRIPTION & SPECIFIC OBJECTIVES

• The Quality Center of Excellence (COE) Lead role will involve establishing the Quality COE structure at the Wilmington Biotech site, ensuring the processes conform to the company policies and comply with cGMPs, Health Agency regulations and all other applicable governing regulations, with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.
• Close collaboration with high performance talent from our global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key, and the successful candidate will inspire his/her team to build the future of our company's antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply, that is Right First Time to patients worldwide.
• Providing training and guidance on the interpretation and implementation of our policies and regulatory requirements will also be key priorities for the Associate Director. Throughout the development of the new facility, the successful candidate will focus on commissioning, qualification, and/or validation of the facility, equipment, and process.

POSITION RESPONSIBILITIES

With energy and enthusiasm, the Quality COE Lead will:

• Be responsible for the quality aspects of commissioning, qualification, and validation of facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
• Be involved in all quality-related activities for commissioning, qualification, and validation which are required by o ur Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity.
• Will work closely with stakeholders and SME's from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the qualification and validation process and facilitate continuous improvement.
• Will work on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ, and commercialization
• Will serve as the Quality SME for all validation and ongoing qualification activities across the site including but not limited to: cleaning validation, utilities performance qualification, equipment requalification, new equipment installation.
• Be responsible for the quality aspects of receipt and release of incoming materials for the site.
• Be involved in all quality-related activities for the warehouse and dispensary which are required by our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity.
• Will ensure the site Supplier Quality Management process is established and maintained at the site.
• Will provide quality oversight of the Lab on site and will ensure the Lab operates to our Manufacturing Division Quality Manual requirements.
• Will understand manufacturing process to ensure equipment and facility are compliant with process needs and regulatory expectations.
• Inspire and motivate his / her team to uphold a high-performance culture that drives Quality Assurance excellence.

REPORTING STRUCTURE

This position will report into the Site Quality Lead

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General

• This role requires a seasoned Associate Director with a minimum of 10 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
• A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends

Technical

• Must have at least 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
• Must have 2 years of experience in a commercial QC Lab.
• Preferred to have 2 years experience in supplier quality management including incoming material release.
• Demonstrated knowledge of Cleaning in Place, Cleaning out of Place, Sanitize in Place.
• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc).
• Exceptional analytical, problem solving & root-cause analysis skills.
• Ability to multi-task and handle tasks with competing priorities effectively.
• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
• Strong operations support background ensuring value added and effective quality oversight

People

• A great communicator, decisive decision maker and proven ability to deliver excellence
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
• Experience with new product introductions and/or process qualification/technology transfer
• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
• Excellent communication skills (written and oral).
• Required to work on his/her own initiative in addition to working as part of and leading a team. Must be able to work across a team matrix in order to meet accelerated timelines.
• Desire to continuously learn, improve and develop.
• Ability to facilitate groups with diverse perspectives, and influence and bring teams to consensus and alignment.
• Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed.
• Planning and scheduling skills, Proven organizational skills, Flexible approach.
• Goal/results orientated, Starter/Finisher.

Education Requirements:

• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline.

VETJOBS

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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

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 salary range for this role is
$139,600.00 - $219,700.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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.

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Driving Continuous Improvement, GMP Laboratory, Management Process, Quality Management Standards, Quality Management Systems (QMS), Quality Risk Management, Regulatory Compliance, Supplier Quality Management

Preferred Skills:

Job Posting End Date:
07/16/2025
*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:R354994