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.
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.
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.
Strong scientific understanding of analytical methodology and knowledge of relevant regulatory standards and cGMP requirement.
Personal Qualities
Effective English communication skills, both oral and written. 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
Analytical Chemistry, Analytical Chemistry, Analytical Method Development, Analytical Problem Solving, Analytical Thinking, Bioanalysis, Biological Analysis, Change Request Management, Chemical Biology, Communication, Continuous Improvement Tools, Counterfeit Detection, Cross-Functional Teamwork, Escalation Management, Identifying Customer Needs, Innovation, Leadership, Medicinal Chemistry, Microbiological Analysis, People Management, Pharmaceutical Manufacturing, Pharmaceutical Systems, Quality Control Management, Quality Initiatives, Quality Management {+ 4 more}
Preferred Skills
Current Employees apply HERE
Current Contingent Workers apply HERE
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
Not Applicable
Shift
Valid Driving License
Hazardous Material(s)
Job Posting End Date
01/23/2026
A job posting is effective until PM 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 R379336
Show more Show less
-
Kumagaya MSDThe 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. · Ensures all analytical te ...
-
Kumagaya MSD Full timeThe Associate Director in Quality Control will lead quality control laboratory analysts and manage relevant testing for raw materials components finished drug substances or final drug product ensuring high standards of quality compliance within our organization. · ...
-
Saitama MSD Full time+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. · +Bachelor's degree in sc ...
-
Quality Control Lead
1週間前
Saitama PERSOL CAREER BRS (Bilingual Recruitment Solutions)品質管理部門を率いるチームの一員として働くことになります。製品の品質を保証するために、原材料から最終製品までの品質を確保するため、製造、品質保証、規制対応など他部門と連携しながら業務を遂行します。 · ...
-
Saitama, Saitama UCB ￥2,000,000 - ￥2,800,000 per yearQuality Control (QC) Lead reports to Head of Saitama Site and oversees the QC department to ensure product quality from incoming materials to outgoing products based on GMP and Japan Pharmacopeia (JP). The position is part of Site Leadership Team (SLT) and oversee entire activiti ...
-
Chiyoda, Tokyo Johnson & Johnson MedTech ￥10,000,000 - ￥15,000,000 per year品質マネジメントシステムの構築、維持、改善をリードする。品質目標を理解し、自グループの目標及び測定指標の設定に参画し、行動を計画、実行、それに伴いチームをリードする。新製品導入及び製品販売終了活動において、品質保証に係る活動を取りまとめる。 · 品質マネジメントシステムの構築、維持、改善をリードする · 品質目標を理解し、自グループの目標及び測定指標の設定に参画し、行動を計画、実行、それに伴いチームをリードする · 新製品導入及び製品販売終了活動において、品質保証に係る活動を取りまとめる · 医療機器/医薬品/医薬部外品業界における品質保証または品質管理 ...
-
Namegawa, Saitama SyntegonExcellent opportunity to join Syntegon Technology K.K. as a Purchasing Expert in Tokyo! As part of our global team of over 6,100 colleagues in more than 15 countries, you will contribute to delivering intelligent and sustainable technologies for the pharmaceutical industry. · ...
-
Cluster Lead
2ヶ月前
Chiyoda, Tokyo HCLTech ￥15,000,000 - ￥25,000,000 per yearWe are seeking a highly experienced Cluster Lead to oversee functional testing and validation across Legal, Compliance, Client Onboarding, and Treasury Operations domains. · Lead end-to-end functional testing & validation across Legal, Compliance, Client Onboarding, and Treasury ...
-
Chiyoda, Tokyo Johnson & Johnson Innovative Medicine ￥6,000,000 - ￥12,000,000 per yearA Senior, Local Trial Manager is a mid-level trial management role responsible for local management of a clinical trial in a country or countries. The role is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that ar ...
-
Chiyoda, Tokyo Citi ￥10,000,000 - ￥20,000,000 per yearCiti continues to enhance its business control and governance framework by building out Institutional Credit Management (ICM), a first line of defense business line, to house and consistently manage credit risk activities performed for Citi's institutional clients. ICM's objectiv ...
-
Chiyoda, Tokyo Johnson & Johnson Innovative Medicine ￥600,000 - ￥1,000,000 per yearTo conduct change control of approved products appropriately as CMC-regulatory affairs (CMC-RA). · ...
-
Chiyoda, Tokyo SWAROVSKI ￥400,000 - ￥800,000 per yeareCommerce Business Support plays an essential role supporting the daily operation and commercial success of Japan's 3rd party e-commerce accounts. · This position requires a collaborative mindset and a strong sense of responsibility, as it contributes directly to driving sales an ...
-
Chiyoda, Tokyo Citi ￥7,000,000 - ￥14,000,000 per yearThe Securities & Derivatives Sr Manager is a senior management level position responsible for accomplishing results through the management of a team or department. · ...
-
Chiyoda, Tokyo Citi ￥2,000,000 - ￥2,500,000 per yearThe FX Operations Manager is a senior management level position responsible for accomplishing results through the management of a team or department. · ...
-
Chiyoda, Tokyo Citi+ Manage the comprehensive corporate secretarial duties for our key legal entities. · + Adapt to firm-wide norms and system requirements, · + Address financial controls and risk control mandates. · Responsibilities:Corporate Secretarial & Governance Management · Regulatory Compli ...
-
Chiyoda, Tokyo Johnson & Johnson Innovative Medicine ￥5,000,000 - ￥10,000,000 per yearThe job is a senior local trial manager position at Johnson & Johnson in Japan. The job involves leading local trial teams to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs ...
-
Chiyoda, Tokyo Johnson & Johnson Innovative Medicine ￥6,000,000 - ￥12,000,000 per yearLead Local Trial Manager responsible for local management of clinical trials in Japan. · ...
-
Chiyoda, Tokyo Citi ￥5,000,000 - ￥15,000,000 per yearWe are looking for an experienced and highly motivated individual to join our team in Tokyo, Japan as a Global Solution Sales. The Global Solution Sales role sits within TTS team in Japan and provides a unique opportunity to manage a portfolio of essentially Japan-based Global co ...
-
Chiyoda, Tokyo Qnity ￥120,000 - ￥180,000 per yearWe are seeking a Contract Manufacturing Manager to join our team in Tokyo, Japan. As a Contract Manufacturing Manager, you will be responsible for managing contract manufacturers within the designated region, ensuring proper engineering, technical, and process safety support is p ...
-
Chiyoda, Tokyo Johnson & Johnson Innovative Medicine $750,000 - $1,000,000 per yearWe are hiring for a CAR-T Cell Collection Technician/Supervisor to be located in Japan and reporting to the manager in APAC region. · CAR-T commercial supply chain technician/supervisor is responsible to manage the contracts and communication with third party suppliers including ...
-
Chiyoda, Tokyo Citi ￥800,000 - ￥2,400,000 per yearA senior manager in Cash Equity Middle Office is responsible for managing a team to process orders and transactions, ensuring seamless delivery of securities transactions. · ...
