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Senior Manager, Quality Keytruda Job

Date: Oct 26, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: REL000372


  • This position will have the responsibility for Biotech IPT laboratories services and their related support team in Biotech.

  • The laboratory Senior Manager has responsibility for analytical support to MSD Singapore under his/her job scope.

  • The laboratory Senior Manager is responsible for ensuring all analytical activities on site comply with cGMP requirements.The Senior Manager assures compliance with all safety and environmental requirements

  • Manage all aspects of activities related to Biotech IPT laboratories.

  • Lead the team to deliver relevant laboratory supports which are timely, cost effective and efficient and GMP / business compliance; provide coaching and mentoring for personal and professional development of staff.

  • Assures that appropriate information on the quality of excipients and in-process control points is provided to support process optimization studies with a clear linkage to Quality by Design and regulatory filing requirements. In conjunction with the stability group, determines the appropriate expiry dating for each drug substance/product.

  • Contributes to the development of appropriate specifications for assuring the quality of drug substances and products throughout the expiry period and for inclusion in the CMC sections of IND amendments and WMA/NDA submissions. Provides the analytical CMC information for filings and responses to queries from worldwide regulatory agencies in connection with this information to support marketing approvals.

  • Manages the quality testing in support of all supply products manufactured at MSD Singapore. This will be completed in a cGMP compliant manner to meet all relevant customer/site target dates.

  • Ensure Quality systems are continually audited/reviewed and new requirements are identified and implement. Maintains training status in the department at the required level for roles and responsibilities of each job.

  • Maintains outside contacts in the scientific community, universities, government and other outside laboratories in relation to analytical chemistry. Monitors industry trends, new technology initiatives and worldwide analytical regulatory guidance.

  • Manages the preparation of the departmental capital and expense budgets and operation within approved funds.

  • Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; preparing/updating the training curriculum for each position in his/her area of responsibility; assuring compliance with the training requirements for each employee; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

  • Provide SME support to all utility & facility operations.

  • Participate in SHE, Business Compliance, cGMP and all other compliance-related matters, where applicable. This can include specific duties involving in maintaining qualified status of equipment by timely application of and reporting exceptions to the GMP systems supporting the qualified state.

  • Any other duties as assigned by the Executive Director.
Qualifications


  • Master / Bachelor degree in a related Science (Microbiology) or proven relevant experience in the pharmaceutical industry.

  • 8-10 years relevant quality control, quality assurance experience in a relevant regulated manufacturing environment, preferably pharmaceuticals.

  • Good knowledge and application of GMP.

  • Technically competent.

  • Proven managerial / supervisory experience preferred.

  • Ability to access impact and make decisions and take accountability

  • Able to see the big picture, versatile, meticulous, self-motivated, able to work under pressure

  • Ability to build, develop and lead a high performance team, good people management and team working ability with people at all levels

  • Exhibits good leader behaviors and interpersonal skills

  • Continuous improvement mindset

  • Analytical development mindset in research and commercialization activities

    Other Personal Attributes:
    • Strategic Agility
    • Problem Solving Abilities
    • Building Effective Teams
    • Business Acumen
    • Conflict Management
    • Motivating Others



Job: Release Control
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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