Functie beschrijving

Wat je gaat doen

Responsible for leading a department (± 40fte) that consist out of professionals who collaborate with both internal as external stakeholders to assure quality oversight of all business processes required to successfully disposition pharmaceutical products in line with both customer as well as regulatory expectations.

Creating Quality Oversight by leading 4 teams with different focus areas; QA Systems & compliance, QA Operations, QA projects and Qualified Persons. Fostering a culture of continuous improvement and quality awareness across all business processes.

Assures compliance with GxP regulations and, ISO standards and makes sure (semi-)finished pharmaceutical products meet product specifications.

Assures timely disposition of semi-finished products and finished pharmaceutical products

Responsibilities

Lead cGMP compliance activities for all relevant operations including activities related to manufacturing, testing and release of clinical and commercial pharmaceutical products

Work closely with all operation functions to enforce quality and regulatory requirements and provide quality oversight and leadership across these functions to assure compliance and strong relationships

Lead all quality aspects and deliverables of customers projects to ensure compliance and project progress

Manage all quality related interactions with customers from IND enabling studies to routine GMP operations

Lead and host compliance audits including customer audits and health authorities/regulatory inspections

Lead batch record review, lot disposition, material release, internal audit program, deviation handling, CAPA, change controls and quality events processes

Lead the site Quality Management Review (QMR) and ensure the effectiveness of the Quality Management System

Oversee and support new product introduction, tech transfer and process and analytical qualification activities

Oversee quality aspects of commissioning, qualification and validation activities for the facilities, utilities equipment and computerized systems

Drives the quality oversight onValidation Master Plan, validation protocols and reports

Lead and drive risk assessments and the implementation of the contamination control program

Develop, author, review, and/or approve Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed

Actively manage a group of QA personnel and oversee their performance management, mentoring, and career development in line with their strengths

Develop and manage departmental goals and corresponding budget in alignment with corporate vision and goals.

About the department

Our Quality Assurance (QA) department is truly part of our primary production process, where we monitor and, where possible, improve various laboratory departments that produce vaccines, raw materials, intermediates and media.

Bilthoven Biologicals is een internationaal biofarmaceutisch productiebedrijf. Met circa 500 collega's werken we samen aan de productie van vaccins, zoals polio-, difterie-tetanus-polio (DTP) en BCG. BBio levert vaccins aan onder andere de World Health Organization (WHO) en UNICEF en helpt zo mee aan het wereldwijde programma om polio de wereld uit te helpen. BBio maakt deel uit van de Poonawalla Group, eigenaar van het Serum Institute of India, de grootste vaccinproducent ter wereld.Daarnaast investeert BBio in modernisering en uitbreiding van onze productiecapaciteit.

Functie eisen

Wat neem je mee

Training and additional qualifications

In-depth knowledge of Good Manufacturing Practices (GMPs), Quality principles, concepts, industry practices, and standards

Experience

10+ years of relevant experience in the pharmaceutical or biopharmaceutical industries, including 7 years of leadership experience, and demonstrated knowledge of relevant cGMP regulations

Master degree in Life Sciences or related field

Experience with Vaccines, Biotechnological products preferred

Experience in client-focused development and manufacturing organizations preferred

Demonstrated leadership with strong communication skills (both verbal and technical) and an ability to deliver results through teamwork

Competences

Must show leadership; have the ability to connect, to lead by example, have the ability to listen, must be approachable, have to ability to take decisions, to be integer.

Must be able to analyze processes, lead improvement activities, and empower staff to create a lean culture

Must think critically and creatively and be able to work independently, determine appropriate resources for resolution of problems, and have strong organizational and planning skills

In-depth knowledge of Quality principles, concepts, industry practices, and standards

Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function

Self-motivated and passionate about advancing the field of vaccines / biotechnological products

Self-awareness, integrity, authenticity, and a growth mindset.

Key stakeholders:

Internal: Manufacturing, MS&T, Supply Chain, Regulatory Affairs, Quality Control, Marketing&Sales, Maintenance & Engineering

External: customers, suppliers, certification bodies, regulators

Wij bieden

As a QA Director, you could hardly wish for a better place. You will have the opportunity and the freedom to let the department take steps and further prepare for our current and future products, which help to keep the world's population healthy.

As a member of the OT, you have a direct influence on business operations and work with the Director of Manufacturing and the COO on business operations. Not only in the Netherlands, but also with our international owner, the Cyrus Poonawalla Group

Of course, you can count on an appropriate remuneration structure (the salary range at the top of the vacancy is only indicative) and on our discreet handling of your application.

Overige opmerkingen

Do you recognize yourself in the above and does the vacancy appeal to you? Then we look forward to receiving your application! Do you have any questions about the application process? Please contact our recruiter, Elias Brouwer via elias.brouwer@bbio.nl

Het bedrijf

Bilthoven Biologicals is een internationaal biofarmaceutisch productiebedrijf. Met circa 500 collega's werken we samen aan de productie van vaccins, zoals polio-, difterie-tetanus-polio (DTP) en BCG. BBio levert vaccins aan onder andere de World Health Organization (WHO) en UNICEF en helpt zo mee aan het wereldwijde programma om polio de wereld uit te helpen. BBio maakt deel uit van de Poonawalla Group, eigenaar van het Serum Institute of India, de grootste vaccinproducent ter wereld.

#J-18808-Ljbffr