Associate Director, CTS-APAC Quality

Posted 03 Jan 2024

Singapore, Singapore - Singapore

Req Id 270733

 

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

 


Scope of Responsibility: Leads the Quality organization for CTS APAC comprising sites in Singapore & Shanghai, China. Responsible for the management and oversight of all quality functions supporting a regulated environment e.g. GLP/GMP. Ensures global alignment & effective implementation of the Quality Management Systems and full compliance with all relevant standards.

 

Your Role: Provides effective leadership and guidance to the CTS APAC organization to ensure that Quality objectives meet the necessary standards in line with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and other applicable regulatory requirements to support the ongoing business.

 

Responsible for establishing an effective & high performing Quality organization.

Oversees the identification & remediation of risks & supports cross functional activities to strengthen a Quality culture.

Essential Jb Functions:

  • Recruit, lead, train & develop high performing teams to respond to business demand within quality & regulatory requirements.
  • Actively manage the performance and development of teams using available tools and procedures, ensuring all team members have appropriate goals and objectives set. Teams include people managers and/or supervisor levels.
  • Leverage close collaboration across different geographies (US, EU, APAC) and proactively seek support from key stakeholders to obtain the required input and alignment with Quality strategies.
  • Responsible for ensuring compliance to regulatory standards in the conduct and reporting of work performed.
  • Create, manage & drive effective plans to improve a Quality Culture with defined timelines & KPI reporting.
  • Manage resource and financial planning for the Quality organization to ensure alignment with business needs and quality requirements.
  • Drive the identification of key risks & collaborate on solid mitigation plans.
  • Responsible for strengthening key partnerships with customer Quality organizations.
  • Participate as a senior leader on the Global Quality Leadership Team (GQL) and work closely with other members of site leadership team at the local level.
  • Ensure the review and approval of GxP documents, including Protocols, Technical Specification (TS), Batch Records, Workbooks, SOPs, Validation Protocols, Labels, new component approvals and all other QMS documentation.
  • Ensure the review and approval of quality records e.g. deviations, anomalous results, OOS, positive results, CAPA etc.
  • Oversee the conduct of investigations from events, complaints or data audits.
  • Report and present KPI metrics to senior PSS Quality management or other stakeholders as required.
  • Ensure site readiness to manage client audits, internal audits, and regulatory inspections.
  • Participate in, or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones.
  • Advocate and drive standardization and harmonization of quality approaches and procedures across the global quality framework where appropriate

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Who You Are:

  • Minimum of a B.S. in the Life Sciences, advanced degree preferred.
  • Certification in a Quality related area is beneficial.
  • 8+ years leadership experience in a Quality organization
  • 5+ years in direct line supervision of people
  • 8+ years working in a cGMP environment/FDA/EMA regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and execution.
  • Strong relationship building and negotiation strategies, ability to influence, network, drive and manage change.
  • Experience with regulated products or services in the APAC region preferred.

 

Competencies:

  • Fosters potential and develops talents of top performers within the Quality team.
  • Acts ethically and takes responsibility for quality of own work and that of the Quality organization.
  • Collaborates with various local and global teams to identify and implement improvements.
  • Works with agility, drives and implements change on local and global scales.
  • Applies technology to drive digitalization, improve quality and increase customer value.

 

Knowledge and Skills:

  • Fluent in both written and spoken English & Mandarin
  • Excellent leadership & management skills
  • Excellent communication, interpersonal & conflict resolution skills
  • Excellent working knowledge of implementing, managing & applying QMS in a US/EU/APAC GxP environment
  • Direct experience in communicating with regulatory authorities preferred
  • Leadership skills in managing change, attracting/developing talent, and coupling high performance standards with soft skills.

 

Travel Requirements:

  • 0-20% travel required


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!


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The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

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