Senior QA Manager
London, Central London / West End
A global pharmaceutical company is seeking a Senior Manager of Quality Assurance for their UK QA team. This opportunity will be remotely based anywhere in the UK.The company are going through some rapid growth and are seeking an individual who can work independently and take ownership and managed all QA activities related to third party manufacturing contract facilities.
The incumbent will serve as the Quality Assurance subject matter expert (SME) executing, coordinating and/or overseeing the Quality aspects of outsourced GMP manufacturing, testing and release activities performed by global contract service providers. This position will execute quality systems procedures to ensure manufacturing, release and quality standards are executed and maintained in line with business objectives and in collaboration with key stakeholders on a global basis.
Key Responsibilities include: Work with QA colleagues and cross-functional counterparts in Regulatory, CMC, Manufacturing, Supply Chain and Operations to achieve and maintain compliant and uninterrupted commercial supply. Establish and maintain master production and control records at contract service providers in collaboration with internal stakeholders. Maintain, develop and/or execute internal Quality systems and procedures to support outsourced manufacturing and testing activities and fulfill global marketing authorization holder responsibilities. Coordinate the internal review of manufacturing or testing related complaints, deviations, investigations, change controls, etc. occurring at contract service providers. Liaise with Supply Chain to ensure planning and coordination to achieve the timely review of executed batch records and subsequent product release. Liaise with CMC to ensure planning and coordination to achieve the timely review of qualification/validation protocols, reports or similar GMP related documentation. Assist the applicable Quality site liaison as necessary to support the preparation and/or execution of applicable quality/technical agreements (QTA), participation in and/or support of audit activities; and support for applicable regulatory inspection preparations/responses at individual manufacturing and testing sites. As directed, serve as backup to ensure the review, execution, coordination and/or tracking of any assigned quality assurance or quality control activities. Provide creative, collaborative and responsive approaches to work as part of a multidisciplinary team to ensure quality and compliant outcomes in a timely and cost-effective manner. Design, develop, assemble, monitor and/or present QMS metrics updates and status reports, as assigned. Anticipate, identify, prioritize and/or execute preemptive mitigation of quality risks through cost-effective compliance with all applicable regulatory requirements
Qualifications and Skills Required:
A minimum of a Bachelors degree in pharmacy, pharmaceutical sciences, chemical engineering, chemistry or a related life sciences discipline with at least 12 years of direct experience in the quality assurance/QMS aspects of both pharmaceutical product development and commercialization on a global basis with significant emphasis outside the US, and at least 8 years in a quality department systems management role
Direct experience in the development of innovative quality assurance/QMS systems coupled with demonstrated track record of success in the delivery of cost-effective quality and compliant outcomes in fast-paced, dynamic global organizational environments and must include outsourced operating models. Broad knowledge and direct hands-on experience in Quality oversight of commercial sterile product manufacturing and secondary labeling/packaging is required. The successful candidate will have a demonstrated track record of successful interactions with and oversight of third-party contractors and suppliers and compliance with global quality requirements. The successful candidate will be able to work effectively in a matrix environment through excellent influencing and interpersonal skills. Strong oral and excellent written communication skills are required, along with the ability to manage multiple tasks with competing priorities. This position may require up to 50% domestic and international travel coupled with the ability to effectively execute all responsibilities during travel periods. Availability and working during hours to accommodate other international time zones will be required at times
Please contact Tom Quirke on 020 7822 1710 or email Thomas.Quirke@Clinicalprofessionals.co.uk to discuss this role in more detail.
Posted 51 days ago