QA Manager CSQ
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science- based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
About Clinical Supply Quality Laboratories
The Clinical Supply Quality Laboratories team is part of the Clinical Supply Quality (CSQ) department.
CSQ is responsible for the end-to-end Quality & Compliance oversight for the internal and external clinical supply leading up to the release and certification of Investigational Medicinal Products used in clinical trials.
The group is forward-looking, working on improving processes, being customer oriented and supporting innovation and agility.
We are searching for the best talent for the position of QA Manager CSQ for the Higi laboratory team responsible for quality oversight and support of Synthetics laboratories located at Higi and their contract laboratories.
Purpose
We are looking for a quality-oriented person with an analytical and scientific mindset to join our dynamic multidisciplinary team as a QA Manager that will be responsible for the Higi site compliance and operational compliance of the clinical laboratories. The QA Manager will operationally support the daily activities including review and approval of procedures and documents for the analytical and microbiological activities, manage external audits from heath authorities and customers, support/execute internal audits, conduct check rounds to monitor the compliance of the laboratory areas and the performance of the processes and activities, review and approve quality investigations and change controls, provide quality metrics in support of quality reporting. The QA Manager will closely interact with the other IMSCQ.PQM and CSQ team members, our TDS business partners and other business and quality departments to ensure quality is incorporated in processes and support the informed decision-making process. Together with this exciting function in a dynamic and international environment, we ensure diversity in your work and support personal development.
You will be responsible for
Support, coach, develop team in reaching quality, business and personal objectives
Ensure quality oversight on the TDS laboratories Synthetics Higi and their contract laboratories.
Connect and develop strong relationships with quality and business partners and stakeholders to address issues, opportunities
Proactively and continuously challenge the organizational performance and develop/implement improvements.
Ensure that GMP activities in the laboratories and their contractor laboratories are being executed in compliance with the regulations for IMP and national and international cGMP requirements.
Organize and host quality meetings such as CPA Board, QIP, prepare and support QSMR meetings.
Organize, prepare and support by the team for external audits and inspections e.g. USFDA, EMA, Customer, and internal inspections e.g. global compliance in the TDS laboratories.
Ensure timely review and approval of quality documents to support the development projects and comply with global Johnson & Johnson (J&J) policies, IMP regulations, and national and international cGMP requirements
Ensure that evaluation and approval of events, deviations, and CAPA's are timely performed, the records meet quality and compliance requirements and adequate corrective and preventive actions are taken.
Required skills
Leadership and decision-making skills to meet business objectives and a highly dynamic business environment
People management skills, as direct and/or indirect manager or project manager.
Ability to work in a matrix organization, across organizational boundaries through influencing, negotiation and partnering.
Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering in a global environment.
Excellent organization and interpersonal skills; ability to work with various partners and influence decision processes.
General knowledge of pharmaceutical product development and understand how analytics contribute to this process.
Up-to date knowledge of applicable regulations and industry standards.
In depth scientific and analytical knowledge, ability to quickly assimilate new requirements, new modalities such as techniques, product types.
Clear understanding and ability to perform risk assessment and develop/provide appropriate actions to mitigate Risks to an acceptable level.
Experience with regulatory inspections as spokesperson, backroom role, preparation is an asset.
Positively react to changes and show agile behaviour e.g. dealing with different quality levels to support fit for purpose quality in an R&D environment.
Excellent verbal and written communication skills to negotiate and communicate with internal and external customers.
Education / Experience
University Master’s degree or equivalent through experience, scientific orientation (pharmaceutical, chemical or biological sciences)
At least 8-10 years' experience in pharmaceutical industry (laboratory environment, analytical development)
Language proficiency
Fluent both in speaking and writing of English.
IT proficiency
Application supporting quality processes e.g. NC/CPA, Change control, training, document management
MS Office suite.
Required Skills
Preferred Skills
AI Judgement Integration, Business Alignment, Coaching, Collaboration, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility
