Location: Cambridge – (flexible working)
Salary: Up to £65,000 + benefits
Permanent position
Start date: ASAP
My client is looking for a QA Manager with experience managing a CMO or previously worked for a CMO to join on a permanent basis. Must have experience working with solid dosage forms (tablets). Application are welcome from candidates with a clinical or commercial background.
Job Summary:
Responsible for the oversight and execution, from a quality perspective, of chemistry, manufacturing and control (CMC) related activities for assigned drug candidates through all stages of clinical development to global commercialization. Responsibilities include leading the development and implementation of policies, procedures, and protocols to control GMP activities, implementation of QA standards, and adherence to ongoing compliance requirements. The role will involve interaction with the internal project team (and sub-team) members and external suppliers. The Incumbent is expected to exhibit organizational leadership and perform duties without appreciable direction.
Qualifications
• Demonstrated ability to develop and implement procedures which ensure compliance to GMP and regulatory standards.
• Strong technical and analytical knowledge of pharmaceutical manufacturing.
• Demonstrated independent initiative to identify and champion improvements to policies and procedures such that operational compliance is assured.
• Considerable knowledge of drug development process, FDA/EMA/ICH guidelines and GMPs
• Considerable knowledge of validation as applied to pharmaceutical manufacturing, testing and equipment.
• Considerable knowledge of content expectations, preparation and submission activities, specifically in relation to CMC, for regulatory filings in USA, EU and Rest of World.
• Demonstrated project management experience and skills, with the ability to coordinate numerous projects in a demanding, fast-paced environment.
• Excellent oral and written communication skills for effectively interfacing with other departments within the company, suppliers, and other contractors.
• Demonstrated audit conduct and management experience is required.
• Ability to handle complex and challenging situations without appreciable direction.
Education and Experience
• Manager level II: A minimum of eight years of experience in a quality role within a pharmaceutical setting required.
• Manager level I: A minimum of five years of experience in a quality role within a pharmaceutical setting required.
• Expertise in the areas of CMC, Quality, GMP, GDP and Regulatory requirements and guidelines.
Working Conditions
• Office-based position with approximately 25% travel
• Work from home eligible with manager approval
If you are interested in this role then feel free to apply or email directly at [email protected]