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 deliverablesManage 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 ManagementPreferred 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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
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.
Requisition ID:R380857
-
Saitama MSD Full time$1,000,000 - $1,200,000 per year+Job summary+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.+ · +Essent ...
-
Kumagaya, Saitama 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 test ...
-
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 ...
-
Kumagaya MSD Full timeThe 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. · ...
-
〒- 埼玉県 熊谷市 西城, MSD品質管理担当アソシエイトディレクターは、品質管理ラボ分析担当者チームを率い、原材料、成分、最終原薬、または最終医薬品に関する品質試験を管理する重要な役割を担います。この役割は、組織内の高い品質基準とコンプライアンスを確保・維持することです。 · ...
-
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 ...
-
Commodity Manager
1週間前
Saitama Faurecia Full timeWe pioneer technology for mobility experience that matter to people. · ...
-
Saitama Amazon Full timeAmazon is looking for staffing leads that are motivated to lead mass recruitment programs for Amazon's logistics sites. · ...
-
Service Engineer
1ヶ月前
〒- 東京都 北区 浮間, Watson Marlow Fluid Technology SolutionsWe are seeking a talented and motivated Service Engineer to join our dynamic team. · We are seeking an enthusiastic and skilled service engineer to handle on-site service, repair, maintenance, and warranty claims for our sinusoidal and peristaltic pumps. This role will involve on ...
-
Tokyo オリンパス株式会社グローバル物流・輸送管理の観点からリージョナルの物流オペレーションを支援し、マネジメントを行うことで医療現場への安定供給と品質向上を実現します。 · ...
-
Tokyo オリンパス株式会社オリンパスのサプライチェーン全体像を深く理解することができます。海外拠点や国際輸送サプライヤーとグローバル/クロスボーダーに連携し、様々な部門と協業しながら国際経験を積むことができます。 · ...
-
Tokyo Vestas Full timeWe are dedicated to delivering projects to our customers across the Asia region. · We execute Wind Turbine Supply/Installation projects within scope, · on budget · , on schedule · ,and with impeccable quality.Support Project Manager in initiating planning controlling closing all ...
-
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 ...
-
Tokyo, Tokyo BioMarin Pharmaceutical Inc. ￥8,000,000 - ￥12,000,000 per yearThis position reports to the Associate Director of In Market Quality and will maintain responsibility, oversight, and management of quality-related activities for drug product releases to Japan and APAC region as required. · The Quality Assurance Manager is responsible for the su ...
-
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. · ...
-
Minato Entegris++We are seeking a dynamic Senior Engineer in our Materials Quality Engineering team for our regional Japan supplier base and Japan manufacturing operations. · +Support new product development and the existing supplier base to lead onsite assessment and qualification of materials ...
-
Minato EntegrisWe are seeking a dynamic Senior This position will support the Materials Solutions Division and manage a raw material portfolio critical to supporting our Dry Process Solutions business unit. · ...
-
Tokyo Thermo Fisher ScientificThis is a job for Head of Marketing in IDD Japan. The role involves developing and implementing downstream marketing strategies to drive product adoption and revenue growth for infectious disease diagnostics products. · ...
-
Chiyoda MSD Full timeWe aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. · Join our team as an Associate Direct ...
-
Chiyoda MSD Full time+We aspire to be the premier research-intensive biopharmaceutical company. At our company, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. · ...
-
Tokyo myGwork - LGBTQ+ Business Community $1,200,000 - $1,500,000 per yearThis role involves developing downstream marketing strategies to drive product adoption and revenue growth for infectious disease diagnostics products. · Develop and implement downstream marketing strategies. · Collaborate with sales teams to create go-to-market plans. · Conduct ...
