Quality Assurance Manager

Description

We are seeking an experienced and motivated Quality Assurance Manager to join our Quality Assurance team. This role is responsible for maintaining and enhancing the Quality Management System (QMS), ensuring compliance with global regulatory requirements, and driving continuous quality improvement across the organization.

The successful candidate will lead internal and external audit activities, support regulatory inspections, oversee quality systems and documentation, and collaborate with stakeholders across the business to promote a culture of quality and compliance.

What You'll do

• Maintain and continuously improve the Quality Management System (QMS).
• Provide guidance and consultation to staff on quality and regulatory compliance matters.
• Plan, manage, conduct, and report internal audits, vendor audits, and GPvP audits.
• Facilitate regulatory inspections and accreditation audits.
• Manage customer audits, including pre-study and active study audits.
• Oversee the review, update, and maintenance of Standard Operating Procedures (SOPs).
• Monitor and communicate changes in local and global regulations relating to clinical research and quality activities.
• Maintain and manage the Corrective and Preventive Action (CAPA) system and database.
• Lead continuous improvement initiatives arising from audit findings, inspections, and quality reviews.
• Host and support ISO accreditation audits.
• Support quality-related activities, including Computer System Validation (CSV), vendor management, training, and quality reviews.
• Collaborate with cross-functional teams and subject matter experts to ensure compliance and quality excellence.
• Provide leadership, coaching, and support to Quality Assurance team members.
• Perform additional Quality Assurance responsibilities as assigned by the Head of Quality Assurance.
  
  

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

Requirements

Education

• Bachelor's degree in a relevant scientific, healthcare, or life sciences discipline.
• Master's degree preferred.
• Equivalent professional experience will also be considered.
  
  

Experience

• Minimum of 8 years experience in the pharmaceutical, biotechnology, CRO, or life sciences industry.
• Strong background in Quality Assurance and auditing.
• Experience managing internal, vendor, customer, and regulatory audits.
• Proven experience supporting regulatory inspections and quality systems.
• Previous people management or supervisory experience preferred.
  
  

Skills & Competencies

• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements.
• Excellent written and verbal communication skills in English.
• Advanced Microsoft Office and document management skills.
• Strong organizational and time management abilities.
• Ability to prioritize multiple tasks and meet deadlines.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong attention to detail and accuracy.
• Effective administrative and documentation skills.
• Ability to work independently and use initiative.
• Flexible and adaptable, with the ability to work effectively under pressure.
• Strong stakeholder management and relationship-building skills.
• Ability to influence and gain credibility across all levels of the organization.
• Excellent negotiation and conflict-resolution skills.
• Strong leadership and supervisory capabilities.
• Professional, approachable, trustworthy, and committed to maintaining confidentiality.
  
  

Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.

Benefits

• Competitive salary
• Flexible working hours
• Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)
• Medical Insurance for self and immediate family
• Gratuity
• Accidental Coverage
• Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)