Manufacturing Division Quality Control Associate Director

Job Description

Skills)

Job Description In Primary Posting Language (Include Requirements For Education, Experience And Skills)

Position Overview

The position of Associate Director in Quality Control will play a key role in leading a team of quality control laboratory analysts and managing the relevant quality testing for raw materials, components, finished drug substances or final drug product. The role will ensure and maintain high standards of quality and compliance within our organization.

Essential Functions and Responsibilities (includes, but are not limited to):

The Associate director, Quality Control is responsible for:

• Ensures all analytical testing activities in the laboratory comply with cGMP as well as safety and environmental requirements. Ensures testing is completed in a timely and cost-effective manner to meet supply targets.
• Ensures quality systems are continuously reviewed and new requirements are identified with necessary action taken. Leads laboratory investigation in accordance with guideline and cGMP requirements. Implement robust and sustainable corrective and preventive actions in a timely manner.
• Ensures all analysts working in the laboratory receive the required cGMP, EHS and role-related training required to work safely and in compliance with regulatory requirement and as defined by their training matrix. Provides coaching and mentoring for personal and professional development of staff.
• Manages the transfer of analytical methods, specifications and development knowledge for the product from development sites and between supply sites.
• Ensures that the safety measures associated with chemical and equipment handling are satisfactory and in compliance with EHS requirements.
• Forecasts resource needs, prepares and manages laboratory capital and expense budgets. Ensure lab is operating within the approved budgets.
• Develops and continuous improvement framework within the team, identifies and implements projects. Actively supports site improvement programs to enhance compliance, productivity; and reduce cycle time, inventory and waste.
• The Associate director, Quality Control is also responsible for: · Strategize and lead key Quality initiatives per Hoshin deliverables
• Manage escalations and stakeholders for the respective operations, including financial targets and related efficiency and productivity KPIs for the overall team.

Qualification and Skills Requirements (Includes but are not limited to)

Qualifications & Experience

Bachelor’s degree in science/ Life Science, Analytical Chemistry, Pharmaceutical Science, Engineering or proven relevant experience.

• Minimum 8 years of applied professional work experience in the quality operations/quality control in pharmaceutical manufacturing, with at least 3 years of people management experience.

• Demonstrated experience in change and project management with ability to lead a cross functional high-performance team.

•Strong scientific understanding of analytical methodology and knowledge of relevant regulatory standards and cGMP requirement.

Personal Qualities

• Effective English and Japanese communication skills, both oral and written (mandatory). Ability to work effectively on cross- functional teams as a leader or a core member.

• Demonstrated people management skills and ability to influence /collaborate with stakeholders at senior levels.

• Customer focus with strong business acumen and continuous improvement mindset.

• Strategic and critical thinking mindset with a collaborative and problem-solving attitude.

• Strong communication and interpersonal skills.

• Passionate in coaching and mentoring with a focus on creating an inclusive culture.

Required Skills:

Accountability, Achieving Objectives, Adaptability, CAPA Management, cGMP Regulations, Compliance Analysis, Corrective Action Management, Deviation Management, Laboratory Information Management System (LIMS), Leadership, Manufacturing, People Leadership, Quality Control Management, Quality Manuals, Quality Risk Management, Regulatory Experience, Strategic Thinking, Team Management

Preferred Skills:

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/30/2026

*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.