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About the Role
You will be responsible for the daily management of a team of highly qualified scientists and Subject Matter Experts.
You will be overall responsible for the quality oversight for our cGMP Material Management area, approved according to the European Directive 2001/83/EC, 2017/1572 as well as FDA 21 CFR 210 and 211, as well as the ICH Q7 guideline. Your area of responsibility will include supporting the current manufacturing facility and the new expanded facility.
At AGC, we use a risk-based approach to keep our policies updated with current regulatory expectations as well as business expectations. In the QA Material Management team this is done in close collaboration with our stakeholders in Manufacturing, Quality Control, Supply Chain Management, Process Validation, Process Transfer, and Development.
You will be actively involved in the constant development within our field and the continuous improvement of our quality system. Ensuring that the internal stakeholders comply with standards for cGMP production, i.e., EU GMP, CFR 21 and ICH guidelines, and you will be an important collaborator on defining worldwide policies as well as ensuring quality oversight and compliance of procedures.
You will work with the Supplier Qualification team responsible for the supplier management program, supporting the site manufacturing of clinical and commercial drug substances. This role requires attention to detail, organization, and comfort in interacting cross-functionally with internal and external partners.
About the QA Material Management Team
The QA Material Management team is an important part of the Quality organization. You will be joining a diverse team of highly qualified colleagues, all with several years of experience in quality assurance.
You will cover strategic and tactical leadership for the QA Material Management team and be responsible for procedures and policies for material qualification as well as compliance for GMP materials to applicable international regulatory requirements. Additionally, the team is an active contributor to customer audits and regulatory inspections.
Principal Responsibilities:
- Provide leadership and vision to drive a quality culture by developing a risk-based quality strategy to ensure business goals.
- Ensuring a staff training program and a talent management program for the team.
- Budget responsible for the department.
- Overall responsible for ensuring quality oversight for the GMP Material Management area.
- Ensure effective and compliant material qualification processes and engage in cross-functional planning to leverage resources to improve the speed of resolution.
- Partner with community peers at the operational sites to share and adopt best practices across the AGC network to drive continuous improvement.
- Align local procedures and policies with global policies. Partner with global quality teams to set a “state of art” policy for GMP material qualification, procurement, storage, validation, and use.
- Routinely participate in internal and external audits and inspections.
- Contribute to Annual Product Review and BLA process for commercial projects.
- Ensure execution of Approved Supplier Program for the site.
- Optimize the supplier quality program through management of or participation in continuous improvement projects.
Qualifications:
A manager with analytical and problem-solving skills. Strong decision-making skills and a “can do” attitude. The ability to work in a fast-paced, matrix environment is essential. Capable of working on short deadlines and prioritizing multiple tasks. Flexibility to meet changing needs and business priorities. Strong ability to work independently.
You will recognize the following:
- Expertise in regulatory requirements for a risk-based approach to GMP material management.
- Skilled in strategic thinking, communication and negotiation.
- Actively develops and maintains strong professional relationships building trust and respect across the organization.
- Lead through influence, effectively build alignment and collaborate with multiple stakeholders.
- Facilitate organizational change related to validation across multiple functions.
- Identify performance roadblocks and develop appropriate solutions.
Education/Experience:
- Sc. in chemistry or life sciences or equivalent experience.
- 10+ years of relevant experience in a pharmaceutical or GMP environment.
- Direct experience in team management is required.
- Management experience, including a demonstrated ability to effectively manage staff and multiple tasks utilizing organization and prioritization skills, driven to meet timelines, and results-orientated.
For further information, please contact Lise Marie Christensen at [email protected]
For agencies, please contact our Talent Acquisition team at [email protected]
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AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 28.7.2022, men kan have været deaktiveret og genaktiveret igen.
- Øvrige
- København
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