Clinigen is a leading global specialty pharmaceutical and services company dedicated to improving patient outcomes through the secure and timely delivery of vital medicines worldwide. With over 1,100 employees and operations spanning the UK, US, EU, JAPAC, and South Africa, Clinigen continues to experience significant growth and innovation in the pharmaceutical sector.
Position Overview:
We are seeking an experienced and highly motivated Quality Assurance Senior Manager to join our dynamic team. The successful candidate will play a critical role in overseeing the quality assurance functions across multiple divisions, ensuring compliance with applicable regulatory standards and internal policies. This senior management position demands exemplary leadership skills, strategic thinking, and a commitment to fostering a culture of quality and continuous improvement within the organization.
Key Responsibilities:
- Provide strategic leadership and direction for all Quality Assurance activities within Clinigen to ensure compliance with GxP regulations and other relevant quality standards.
- Develop, implement, and maintain quality management systems that support the company’s operational and commercial objectives.
- Lead and mentor a team of quality professionals, promoting professional development and high performance.
- Ensure readiness for regulatory inspections and client audits, including managing audit responses and corrective action plans.
- Collaborate cross-functionally with departments such as Regulatory Affairs, Manufacturing, and Distribution to embed quality principles throughout the business.
- Monitor and report on quality metrics, driving continuous improvement initiatives and risk mitigation strategies.
- Ensure compliance with applicable legislation including the Misuse of Drugs Act, EU Falsified Medicines Directive, and other relevant regulations.
Requirements
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field; advanced qualifications or certifications in Quality Assurance are highly desirable.
- Extensive experience (minimum 8 years) in Quality Assurance within the pharmaceutical industry, including experience in a senior management capacity.
- In-depth knowledge of global pharmaceutical regulations including GxP, GDP, EU legislation (EudraLex), and the Human Medicines Regulations.
- Proven ability to lead and develop high-performing teams within a regulated environment.
- Strong analytical, problem-solving, and decision-making skills with a strategic mindset.
- Exceptional communication and interpersonal skills, capable of influencing stakeholders at all levels.
- Experience managing regulatory inspections and client audits successfully.
- Demonstrable commitment to continuous improvement and quality culture enhancement.
- Ability to manage multiple priorities effectively under tight deadlines.
Benefits
In return for your valuable contributions and commitment to our organization, we are pleased to offer you an attractive and comprehensive benefits package that includes:
- A competitive monthly salary that reflects your experience, skills, and the industry standards, ensuring that you are fairly compensated for your hard work and dedication.
- A performance bonus designed to reward exceptional performance and achievements, providing you with additional financial incentives as you excel in your role.
- Ongoing professional development opportunities, including training programs, workshops, and access to resources that will help you enhance your skills and advance your career within our organization.
