Assoc. Dir., Quality Management Systems Lead

Job Description

JOB DESCRIPTION & SPECIFIC OBJECTIVES

The Quality Management System (QMS) Lead role will involve establishing the QMS structure at our Company Wilmington Biotech site ensuring the processes conform to our Companys policies and comply with cGMPs Health Agency regulations and all other applicable governing regulations with the mission and ambition to manufacture breakthrough medicines for patients around the world.

Close collaboration with high performance talent from our Companys global team and the biotechnology industry to develop and execute multiple Quality Management Systems and processes will be key and the successful candidate will inspire his/her team to build the future of our Companys 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 Company 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 Management System Lead will:

• Establish and maintain a robust Quality Management System in alignment with our Company Manufacturing Division QMS.

• Responsible for ensuring that the processes for the manufacture of biologics (Drug Substance and Drug Product) have been conducted in compliance with GMP the registered marketing authorization and the associated regulatory requirements.

• In-depth knowledge of US and European GMP guidelines ICH and other international regulatory requirements as applicable to the site.

• Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.

• Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.

• Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.

• Responsibility for adhering to domestic and international GMP regulations cGMPs company policies leadership behaviors and performance.

• Responsible for managing the site Quality Management Systems (Change Controls Documentation Management CAPAs Audit Readiness SQM APQR QRM Customer Satisfaction Product Return and Recall).

• Manage and support external cGMP audits e.g. from Regulatory Authorities and Global Quality including responses.

• Responsible to manage and support APQR activities in partnership with relevant site teams Support Site Governance in relation to Quality Council Process.

• Be an advocate of continuous improvement in the Quality Management Systems.

• Responsible for the site auditing team including installing the permanent inspection readiness program.

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-focussed the successful candidate will have strong contemporary knowledge of relevant cGMPs regulations and current industry trends.

People

• Demonstrated in-depth knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.

• Knowledgeable in Industry Best Practices for quality and compliance related topics.

• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices across the site and Compliance functions on global and local level.

• Proven ability to effectively initiate and drive change across the site.

• Strong verbal and written communication skills project management skills.

• Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.

• Demonstrated ability to make and act on decisions while balancing speed quality and risk.

• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.

• Must have previous managerial experience.

Education Minimum Requirement:

• B.S M.S or PHD in Chemistry Biology Microbiology Automation Engineering or equivalent.

Required Experience and Skills

• Minimum of 10 years experience in Quality Control Quality Assurance or Pharmaceutical Vaccine or Biological Operations or Technical Operations.

• Experience in Health Authority Inspections

• Strong contemporary knowledge of relevant cGMPs regulations and current industry trends.

• Experience in Quality Management Systems

• Strong management and leadership experience with cross-functional teams

• Strong verbal and written communication skills project management skills.

Preferred Experience and Skills:

• Direct experience in manufacture of antibody drug conjugates and/or sterile manufacturing.

• Knowledgeable in Industry Best Practices for quality and compliance related topics.

• Proven ability to effectively initiate and drive change across the site.

• Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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 anothers thinking and approach problems collectively.

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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 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.

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

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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.

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