Principal Quality Expert

Roles & Responsibilities

Scope of Responsibility: Performs a Principal Quality expert role within a regulated environment e.g. GLP/GMP, leading high priority quality objectives/projects, performing a wide range of routine quality operational activities to support the business, leading/supporting key compliance, quality operational & targeted customer activities (may include global). Interacts with key internal & external stakeholders to ensure alignment & focus on global quality standards/initiatives.

Role: As a seasoned Quality professional, you will be instrumental in performing a wide scope of routine Quality & Compliance activities for the Singapore site in addition to driving and executing priority quality initiatives that may have both local and/or global impact to the business and/or customers. Your primary responsibilities will include:

• Quality Operations Execution: Perform routine quality activities to support the Singapore business including auditing (data, supplier, client etc), QMS record management/review, & other essential compliance & Quality Assurance activities. Act as trainer in key quality tasks as required.
• Compliance and Risk Mitigation: Provide expert support & ensure adherence to relevant compliance requirements, quality standards, and industry regulations. Proactively identify and mitigate quality risks that could impact customer satisfaction or business operations at the local but also global level where applicable.
• Innovation and Continuous Improvement: Contribute to the development and implementation of future-focused quality tools (e.g. digitalization), systems, and methodologies aimed at enhancing operational efficiency, reducing defects, and improving process quality.
• Cross-Functional Collaboration: Partner with internal stakeholders—including Operations, Facilities, Supply Chain, and Project management—to promote a quality-centric culture and ensure consistent execution of quality strategies across the business.
• Customer-Focused Quality Initiatives: Help translate customer-specific requirements into actionable quality plans and programs where required, ensuring timely delivery of solutions that meet or exceed expectations.

Essential Job Functions:

• Conduct key activities supporting revenue generating work such as data auditing, and key quality/compliance activities such as internal/process inspections, supplier audits, client audits, regulatory onsite inspections, QAGs etc.
• Active participation in document and SOP reviews driving global alignment where necessary.
• Lead/support/champion activities on quality management systems and processes including events, CAPA, effectiveness checks, change controls, risk management, procedure alignment etc.
• Act as a quality expert for quality related issues with high risk or high impact to customers.
• Support global Quality Improvement with key improvement initiatives as required.
• Help drive the timely conduct of major customer investigations from events, OOS, complaints and/or data audits, as well as drive effective implementation of key CAPA with significant customer impact.
• Help support/lead local and global quality training programs as required.
• Support QCA where needed with helping to deliver on customer quality expectations for targeted accounts in APAC region that support the Singapore site and/or may have global impact.
• Help drive identification of potential risks, reinforcing best practices, and aligning internal operational stakeholders in mitigation & remediation.
• Liaise with other key stakeholders in effective contamination control strategy both locally and across other CTS sites where required.
• Collaborate across different geographies (US, UK, SNG, DER) and proactively seek support from key stakeholders to obtain the required input and alignment with key high priority quality-based objectives.
• Lead quality focused high priority quality projects/initiatives as directed to drive continuous improvement or increase efficiencies.
• Participate in, or lead other activities as required by Senior Management. This will involve participation in meetings across different time zones.

Education and Experience:

• Minimum of a B.S. in the Life Sciences, advanced degree preferred.
• Certification or high level of technical quality expertise in a Quality related area supporting contract testing
• 7+ years experience within a Quality organization
• 5+ years working in a cGMP/GLP environment/FDA/EMA regulated industry such as pharmaceutical and biopharmaceutical, devices and diagnostics and a track record of quality improvement and support of customers in a services environment.
• Strong relationship building and collaboration, ability to drive and manage change.

Knowledge and Skills:

• Fluent in both written and spoken English, fluency in Mandarin preferred.
• Excellent communication & interpersonal skills (internal & external).
• Excellent working knowledge of applying QMS in a US/UK/SNG/DER GxP environment.
• Strong proficiency in customer communication and relationship management skills, including effective communication techniques.
• Proficient in collecting, analyzing, and reporting quality data, using data visualization tools, and ability to advocate, from a quality impact perspective, for the customer within the organization.
• Direct experience in communicating with customers on quality & regulatory topics.

Tell employers what skills you have

GxP
Relationship Management Skills
CAPA
Remediation
Quality Improvement
Interpersonal Skills
Quality Management Systems
Contamination Control
Risk Management
Customerfocused
Compliance
Customer Quality
Customer Communication
Life Sciences
Manage Change
Data Visualization

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