QAQC Manager

MANFIELD EMPLOYMENT SERVICES PTE LTD; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A biopharmaceutical company in Singapore is seeking a QAQC Manager to oversee all Quality functions, ensuring compliance with regulatory requirements and industry standards. The successful candidate will manage quality budgets, lead cross-functional teams for quality improvements, and implement continuous enhancement of GMP standards. This position requires over 10 years of experience in a pharmaceutical setting, with significant supervisory experience in Quality control and assurance. The role promises a dynamic work environment with a focus on food safety and quality excellence.

Qualifications

• 10+ years of experience in a pharmaceutical plant, with 5 years in a supervisory role.
• Knowledge in food safety management systems and applicable GMP regulations.
• Familiarity with QEHS documents, SOPs, and international standards.

Responsibilities

• Oversee all Quality functions, ensuring compliance with regulatory requirements.
• Lead cross-functional teams to address quality issues and improvements.
• Manage Quality budgets and CAPEX planning, ensuring cost efficiency.
• Implement continuous improvement across GMP and international standards.
• Liaise with Regulatory to ensure compliance with manufacturing quality standards.

Skills

External Audit

cGMP

Quality Control

Food Safety

Quality Management

Quality Assurance

ISO

GMP

Investigation

Chemistry

Food Safety Management

ISO 9001

Change Control

Regulatory Requirements

Laboratory

Audit

EHS

Education

Bachelor’s Degree in Chemistry, Pharmacy or Life/Pharmaceutical Science-related

MBA or Master’s degree in science

Job description

Roles & Responsibilities

QAQC Manager

Our client is a biopharmaceutical company. They are currently seeking for QAQC Manager.

The role of the QAQC Manager includes:

• Oversee the overall management of all Quality functions (Quality Assurance and Quality Control) and activities, ensuring compliance with regulatory and company requirements.
• Lead and collaborate with cross-functional teams through scheduled meetings and reviews to address quality issues, share updates, and drive improvements.
• Manage and analyze Quality budgets and CAPEX planning, ensuring cost efficiency and compliance, in coordination with Regulatory to align on budget plans and any changes.
• Define, monitor, and report on the performance of Quality operations, ensuring that all KPIs are achieved.
• Implement a culture of continuous improvement across GMP and international standards (ISO, FSSC), fostering excellence in quality and food safety systems.
• Liaise with Regulatory and Operations to ensure products are consistently manufactured according to quality standards, specifications, and regulatory requirements. Ensure compliance with GMP, ISO, FSSC, Halal, Kosher, and EHS policies and objectives.
• Oversee certification maintenance (ISO, FSSC, GMP, Halal, Kosher) in alignment with regulatory requirements. Review and maintain QMS documentation required for regulatory file submissions (e.g., active substance Drug Master File (DMF), Certificate of Suitability to European Pharmacopeia (CEP) applications) to meet ICH Common Technical Dossier requirements.
• Ensure timely investigation and closure of non-conformances (deviations, OOS, complaints, recalls/returns) in collaboration with Regulatory to resolve quality / food safety issues, while leading multidisciplinary teams to address GMP process failures ensuring compliance and business continuity.
• Create / review / revise and or approve Quality Management System documentations (e.g., SOP, WI, equipment validation/qualification protocol/report, CAPAs, Change Control, OOS, Deviations Complaints, batch records, etc.) ensuring regulatory and standards requirements are met.
• Collaborate with Regulatory in audit and inspection management, ensuring readiness, compliance to ISO, FSSC and GMP, and complete regulatory documentation, including supplier qualification, evaluation, and approval processes.
• Review and approve risk assessments in coordination with cross-functional teams to evaluate process or system / improvements changes that could impact regulatory, product quality and safety.
• Support Regulatory in fulfilling Management Representative responsibilities for international standards certifications (ISO, FSSC, Halal) and take over or delegated as acting Management Representative when required to ensure continuity.
• Lead recruitment, onboarding, training, mentoring and performance evaluation of Quality staff.
• Perform other duties and responsibilities as assigned by the General Manager from time to time.

Job Requirements

• Bachelor’s Degree in Chemistry, Pharmacy or Life/Pharmaceutical Science-related, or with MBA or Master’s degree in science.
• At least more than 10 years’ related experience in a pharmaceutical plant, preferably GMP site, and with at least 5 years supervision experience in Quality (QA and QC laboratory) setting or managing a large group of people with varied experiences and competencies in a fast-paced and demanding environment.
• PIC/S or ICH GMP-oriented, including knowledge in food safety management system.
• QEHS documents, SOPs, WIs, familiarity with applicable GMP regulatory (PICS Part II, ICH Guidelines (Q1 to Q12), and international standards (ISO 9001, ISO 22000, FSSC 22000, ISO 13485, Halal, Kosher) requirements.

Application Instructions

Interested candidates, please send your detailed resume stating Past Employments, including Reasons of Leaving, Last Drawn Salary for the most recent 2 positions (breakdown of basic salary, allowance, bonuses etc), Expected Basic Salary and availability.

WE REGRET TO INFORM THAT ONLY SHORTLISTED CANDIDATES WILL BE NOTIFIED.

Contact

Manfield Employment Services Pte Ltd (Lic. No: 95C2823)
Posting Personnel: Win Hui
EA Personnel Reg No.: R23115634

Skills

• External Audit
• cGMP
• Quality Control
• Food Safety
• Quality Management
• Quality Assurance
• ISO
• GMP
• Investigation
• Chemistry
• Food Safety Management
• ISO 9001
• Change Control
• Regulatory Requirements
• Laboratory
• Audit
• EHS