Quality Assurance Manager

Quality Assurance Manager

Location: Belgium (remote)

Duration: 12 months initially with possibility of extension

Hours: Full time, 40 hours per week

Requires up to 15% travel to external manufacturing site in Denmark

Imagine your next project as a Quality Assurance Manager, working at the forefront of cutting edge work and technology with one of the leading Pharmaceutical companies in the world!

roles and responsibilities

Provide QA support for External Manufacturer, based in Denmark. Lead QA objectives for 1 specific ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules (drug substance manufacturing).This includes:

• Support the External Quality account owner on tech transfers and projects as assigned.

• The position requires solid knowledge in all quality systems concerning the manufacture of biological drug substance and extensive knowledge of Quality Assurance, Quality Control and Compliance and technology transfers

• Demonstrated ability to operate with a minimum of supervision. Demonstrated ability to take ownership for and lead the resolution of complex Quality and Compliance issues.

• Serve as a contact point within the QA organization of other departments of both Janssen and the external manufacturer with respect to quality relevant subjects. Build relationships and influence external partners to continuously enhance quality culture and business excellence.

• Provide QA oversight for technology transfer including process validation, method transfer and cold chain implementation.

• Review and approve validation related documentation authored by both the external manufacturer and Janssen.

• Perform review of equipment and facility qualification, environmental monitoring, technical documents, supplier qualification, raw material specifications, analytical methods, sampling plans, and master batch records to ensure products and processes comply with cGMP requirements.

• Conduct quality investigations and provide timely input to support close out with a minimum impact on the supply chain.

• Lead the development of corrective action plans and monitor implementation.

• Review batch documentation of products in scope prior to their release by the external manufacturer’s quality unit

• Coordinate change control documentation and approval process.

• Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs.

• Support JJRC audit and regulatory inspection readiness at the external manufacturer for Janssen products. Support response to and follow-up of audit outcomes.

• Pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the relevant level of management is necessary.

• Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.

• Ensure that all relevant QA related concerns at the external manufacturer sites are raised to the External Quality Account Owner.

Position requires travel (up to 15%)  to External Manufacturer’s sites to provide cGMP assistance and quality oversight.

how to succeed

• Bachelors Degree in engineering, science, or an equivalent technical discipline

• Work experience: 10+ years relevant industry experience

• Extensive (> 5 y) knowledge of GMP, specifically biological drug substance experience is preferred (QA and/or production).

• Experience managing quality oversight for production and technology transfer programs

• Able to connect easily, team worker, able to manage across cultures

• Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required

• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

• Ability to quickly process complex information and make critical decisions with limited information

• Proficient in written and spoken English

• Excellent computer proficiency e.g. MS Office, Quality Systems

• Amount of travel: up to 15% of travel required.

benefits

This role offers a very competitive hourly rate. This contract will run for a 12 month duration and has a strong chance of extension. Remote. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. 

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

questions

If you would like some additional information about the role please contact: simone.strong@randstadsourceright.co.uk

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.