*Sr. Manager QA Mammalian
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About the Role
QA Operations consists of highly qualified scientists with various professional backgrounds and several years of experience within Quality Assurance.
The team-members are self-driven, highly motivated and capable of working independently. As the team-members all have various previous GMP/Pharma experience, there is a lot of knowledge accumulated within the team.
The most important day-to-day partners for the QA mammalian team are Manufacturing, the Batch Review Center and the QP-team.
You are expected to be the front person in establishing a strong Quality Culture in the QA Mammalian team and to work across QA, QC, Development, MFG and process validation to ensure collaboration between the stakeholders.
As Sr. Manager in QA you will be responsible for leadership for the QA team covering our Mammalian projects. AGC is building new mammalian production facilities in Søborg with production start 2023. The QA Mammalian team will cover this new site as well as the current facility. The team will to grow to match the new production.
The department has an open communication with focus on a high level of professionalism. We are open-minded and have a high support level to our colleagues in the rest of AGC Biologics A/S - and not least to our international customers. The QA Operations team is characterized by positive and proactive colleagues meeting deadlines through committed and friendly collaboration.
We are actively involved in the constant development within our field and the continuous improvement of our quality system. We ensure that Manufacturing, Enginering, and QC are in compliance with standards for cGMP production, i.e. EU GMP, 21 CFR and ICH guidelines, and you will be a important collaborator on defining the guidelines in AGC locally as well as global.
PRINCIPAL RESPONSIBILITIES:
- Provide leadership and vision to drive a quality culture by developing a riskbased strategy batch disposition to ensure business goals.
- Department management ensuring a staff training program and a talent management program for the team
- Budget responsible for the team.
- Represent QA at customer committee meetings and engage in technical discussions with the customer.
- Drive collaboration across site functions and engage in cross-functional planning to leverage resources to improve speed of resolution
- Partner with community peers at the operational sites to share and adopt best practices across the network to drive continuous improvement.
- Allign local procedures and policies with global policies. Partner with with global quality teams to set a “state of art” policy for batch review and batch disposition
- Routinely participate in internal and external audits and inspections
QUALIFICATIONS :
We look for a Sr. Manager with analytical and problem-solving skills. Strong decision making skills and ‘can do’ attitude. Ability to work in a fast paced, matrix environment is essential. Capable of working to deadlines and prioritize multiple tasks. Flexibility to meet changing needs and priorities of the business. Strong ability to work independently.
You will recognize the following:
- Technical knowledge of mammalian processes upstream and down stream
- Skilled in strategic thinking, managing through systems, communication and negotiation
- LEAN Thinking and experience of driving LEAN processes from a QA perspective
- 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
- Assess performance roadblocks and develop appropriate solutions
- Willing to have difficult conversations, meetings, and make decisions related to readiness of areas for inspection
- Facilitate organizational change related to validation across multiple functions
EDUCATION/EXPERIENCE:
- M.Sc. in chemistry or life sciences or equivalent experience
- 10+ years of relevant experience in a pharmaceutical or FDA/GMP environment
- Direct experience leading or supporting multiple functions in a pharmaceutical, biotech or a regulatory industry requires
- Experience in leading validation of large built projects for facilities as well as utilities and equipment.
- 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
Want to keep posted about our growth and to learn more about our company?
We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !
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
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Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 19.9.2022, men kan have været deaktiveret og genaktiveret igen.
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