The Quality Projects Leader is a critical role responsible for overseeing and ensuring the quality of pharmaceutical products throughout the entire lifecycle. This includes the planning, execution, and monitoring of quality-related activities to ensure compliance with regulatory standards, especially those set by the MHRA, as well as company policies. They work closely with cross-functional teams to drive continuous improvement and maintain the highest standards of product quality.
Reporting directly to the Head of Technical Quality, the Quality Project Leader will give regular updates on project status, risk assessments, and quality metrics by detailed reports and presentations. They will collaborate together to develop strategic quality initiatives and ensure alignment with the overall technical quality objectives of the company.
What you will do
Project Management
- Lead and manage quality projects from initiation to completion, ensuring they are delivered on time and within budget.
- Provide Quality Oversight, support to site and external site projects.
- Develop project plans, timelines, and milestones, and track progress against these benchmarks.
- Coordinate with cross-functional teams, including R&D, manufacturing, regulatory, and supply chain, to ensure alignment and effective communication.
- Identify and mitigate risks associated with quality projects and implement corrective actions as needed.
Quality Assurance and Compliance
- Ensure compliance with all relevant regulatory requirements, particularly MHRA standards, as well as FDA, EMA, and other international regulations.
- Lead inspection readiness activities and meetings including relevant stakeholders.
- Develop and implement quality management systems and processes to support product development, manufacturing, and distribution.
- Conduct regular self-inspections to identify areas for improvement and ensure adherence to MHRA quality standards.
- Lead investigations into quality issues, deviations, and non-conformances, and document findings and corrective actions.
- Support and facilitate customer audits by providing relevant documentation, coordinating audit schedules, and addressing any customer concerns or inquiries.
Continuous Improvement
- Drive continuous improvement initiatives to enhance product quality and operational efficiency.
- Implement best practices and innovative solutions to improve quality processes and systems, with a focus on meeting MHRA guidelines.
- Analyse quality data and metrics to identify trends and areas for improvement.
- Foster a culture of quality and continuous improvement within the organization.
- Support PQ pillar drivers and other pillars within projects to further enhance manufacturing reliability and performance.
Stakeholder Management
- Collaborate with internal and external stakeholders to ensure MHRA quality standards are met.
- Communicate project status, risks, and issues to senior management and stakeholders.
- Build and maintain strong relationships with regulatory authorities, auditors, and other external partners, with particular emphasis on the MHRA.
What you will have
- Minimum of 5 years of experience in quality management within the pharmaceutical industry or Bachelor’s degree in a relevant field such as Pharmacy, Chemistry, Biology, or Engineering.
- Proven track record in managing quality projects and leading cross-functional teams.
- In-depth knowledge of MHRA regulatory requirements and quality standards applicable to the pharmaceutical industry.
Nice to have
- Strong project management skills, including the ability to plan, execute, and monitor projects effectively.
- Excellent problem-solving and analytical skills.
- Exceptional communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
- Communication skill to support implementation of a quality mind set across departments.
- Detail-oriented with a strong commitment to MHRA quality and compliance.
- Proficiency in quality management software and tools.
Our Commitment to Diversity and Inclusion
At Ecolab, we believe the best teams are diverse and inclusive, and we are on a journey to create a workplace where every associate can grow and achieve their best. We are committed to fair and equal treatment of associates and applicants. We recruit, hire, promote, transfer and provide opportunities for advancement on the basis of individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, we will not discriminate against any associate or applicant for employment because of race, religion, colour, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, disability, or status as a covered veteran.
In addition, we are committed to furthering the principles of Equal Employment Opportunity (EEO) through Affirmative Action (AA). Our goal is to fully utilize minority, female, disabled and covered veteran individuals at all levels of the workforce. Ecolab is a place where you can grow your career, own your future and impact what matters.
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