Head of Quality Assurance

2 months ago

Hemel Hempstead, United Kingdom NOVUMGEN Full time

Novumgen – the group of Entrepreneurs and Scientists.


Novumgen is a diverse, integrated specialty pharmaceutical and biological company focused on investing, developing, manufacturing, and supplying innovative products that provide benefits to patients and prescribers. We are focused on delivering life-changing medicines that contribute safety and value to patients, healthcare institutions, and prescribers across the globe. As a company, Novumgen has made a lasting commitment to patient safety, introducing new products to its portfolio while maintaining unrivalled quality and exceptional service to the pharmaceutical industry.


We are currently looking to recruit a Head of Quality this role is rudimentary and requires excellent knowledge and communication skills to ensure a smooth operation.



The Company is on a growth trajectory, and we are looking for candidates who align with our purpose, have an entrepreneurial mindset, and want to make an impact on pharmaceutical research. You will join a friendly, dynamic, and committed international team to deliver consistent results to tight deadlines.

Job Summary

The Head of Quality is a key leadership role responsible for ensuring the highest standards of quality and compliance across all aspects of the organization's operations. Reporting to senior management, the Head of Quality oversees the development, implementation, and maintenance of robust quality management systems to ensure regulatory compliance, product safety, and customer satisfaction.


Responsibilities


  • Develop and implement comprehensive quality management strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) and industry standards (e.g., GMP, GDP, GCP).
  • Provide leadership and direction to the quality assurance and quality control teams, fostering a culture of quality excellence, accountability, and continuous improvement.
  • Establish and monitor key performance indicators (KPIs) to assess and track quality metrics, including product quality, batch release times, deviation/incident rates, and customer complaints.
  • Conduct risk assessments and implement risk management strategies to mitigate quality-related risks throughout the product lifecycle.
  • Lead internal and external audits, including regulatory inspections, ensuring timely resolution of audit findings and implementation of corrective and preventive actions (CAPAs).Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure alignment and integration of quality objectives across the organization.
  • Stay current with evolving regulations, industry trends, and best practices in quality management, and proactively implement necessary changes to maintain compliance and drive continuous improvement.
  • Champion a culture of quality and compliance through training, education, and communication initiatives, ensuring all employees understand their roles and responsibilities in maintaining product quality and safety.
  • Serve as a primary point of contact for regulatory agencies and external partners/vendors on quality-related matters, representing the organization with professionalism and integrity.
  • Drive initiatives to enhance operational efficiency, optimize resource utilization, and reduce costs while maintaining high standards of quality and compliance.


Skills and Qualifications


  • Bachelor's degree in Pharmacy, Chemistry, Biology, or related field; advanced degree (e.g., Master's, PhD) preferred.
  • Extensive experience in quality assurance within the pharmaceutical industry, with at least 5 years in a leadership or management position.
  • Ideally have worked for a generics manufacturer
  • In-depth knowledge of relevant regulations and standards (e.g., FDA, EMA, ICH) governing pharmaceutical manufacturing, distribution, and quality management systems.
  • Proven track record of successful leadership in developing and implementing quality strategies, driving compliance, and leading cross-functional teams in a matrix environment.
  • Strong analytical, problem-solving, and decision-making skills, with the ability to prioritize and manage multiple projects simultaneously.
  • Excellent communication, interpersonal, and influencing skills, with the ability to effectively interact with stakeholders at all levels of the organization.
  • Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma Black Belt) is a plus.

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