Site Name: Singapore - Tuas
Posted Date: Mar 1 2023
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Purpose

To lead QC Systems & Support team accountable for Logistic, Equipment management and Data and Computerized System management. As Quality Control Direct Manager, you will have responsibility for ensuring analytical equipment and computer systems in the lab science space are installed, validated, calibrated and maintained, and ensure laboratory procedures are compliant with regulatory requirements.

Key Responsibilities Area

Technical Responsibilities a) Manages team to assure adherence to team/ department/ site KPIs

• Logistic activities for QC
  • Sample and sampling management
  • QC materials storage and inventory management
• Equipment life cycle management
  • Qualification and decommissioning of QC equipment
  • Coordination of calibration and maintenance plan, including troubleshooting
  • QC business continuity plan, Equipment obsolescence plan, Asset listing up to date and CAPEX budget
• Data and Computerized system management
  • Coordination of monographs/ inspection plans change
  • Guidance, support and technical expertise on SAP/LES related matters
  • Manages the computerized systems lifecycle management and implementation of new computerized systems and associated project deliveries.

b) Participates and supports GMP audits c) Leads and manages complex tasks such as continuous improvements, department/ site projects and initiatives d) Problem Identification and Solving: Identifies and reports problems in QC. Ensures thorough investigation and timely closure with effective CAPA to prevent recurrence. Presents in a timely manner major issues to the management with strategies on their resolution. e) Knowledge management to ensure knowledge retention and effective training f) Ensures all in-use procedures are current and compliant g) Writes/ reviews/ approves required GMP documentations such as SOP, protocols, reports, trend analysis, CAPA, deviation, changes control h) To ensure spendings are within QC budget and write off process managed timely i) Be SME for sampling and sample management People Responsibilities Organization and Management

• Provides leadership, guidance, and development for the team
• Ensures the appropriate staffing of the team to assume assigned workload and future development
• Creates strong team morale and a culture of accountability and ownership
• Ensures continuous improvements of the QC operations
• Ensures safety and security policies and practices are deployed and respected
• Enforces laboratory policies and practices (if applicable)
• Ensures expenditures are within budget
• Works across boundaries across departments and/ or sites

Manage the team.

• Leads and coaches the team
• Defines objectives for the team and team members.
• Develops each team member to be equipped with the required knowledge and competencies.
• Empowers team members and maintaining leadership and guidance to the team.
• Manages the priorities of the team.
• Support to another team
  • Ensures adequate support to another team is provided when necessary.
  • Works together with all QC managers to ensure cohesiveness of the QC team.
  • Deputizes for Senior manager.
• Addresses team conflicts
• Works with team leads and supervisor to align the priorities of the team with those of the department.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• At least University basic degree in a Science or Engineering discipline
• >8 years of experiences in pharmaceutical industry or related regulatory fields and with supervisory experience
• Experience in working in a globalized complex organization.
• Concrete experience in Logistics -storage & inventory management, sample handling, sampling.
• Managerial experience - handled at least medium sized team.
• Sound and good GMP practice
• Computerized systems (SAP, LIMS)
• Equipment qualification

#Li-GSK GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK\'s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.