Time left to apply End Date: December 31, 2024 (17 days left to apply)
job requisition id JR101314
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.
JOB SUMMARY
The Head of Quality Control builds and leads a team of technical experts including scientists and technical staff. This role is responsible for quality control across departments; establishes quality control processes and standards based on company policies and external requirements.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
1. Acceptance or rejection of starting materials, packaging materials and intermediate products
2. Approving specifications, sampling instructions, and testing instructions in accordance with §14 Section 1 and ensuring that they are followed
3. Ensure that all required testing has been performed
4. Approval of the commissioning as well as supervision of the analytical laboratories acting on behalf
5. Control of maintenance, facilities and equipment for the performance of tests
6. Ensuring that the necessary validations of the test procedures are carried out
7. Ensure required initial and ongoing training of personnel working in the field of testing
Management
1. Independent and responsible management of the QC in coordination with the Head of Quality and on the basis of the AGC & Quality Strategy, in the sense of the adopted corporate planning and the approved budget
Strategy, planning and monitoring
1. Implementation and monitoring annual AGC objectives (people, quality, processes, growth, finance, customer) with regards to QC
2. Responsibility for CAPEX (incl. System implementations) projects within the QC
Human resources
1. Professional and disciplinary management of subordinate positions
2. Conducting regular meetings with subordinate positions and ensure that subordinates hold regular meetings with their direct reports in this regard
3. Coordinate Staffing with Head of Quality
4. Initiation of QC specific training and development measures
Processes
1. Process responsibility incl. KPIs for defined core processes of QC as Process Owner e.g. Method Validation, Raw Materials Release, In Process Control, Batch Release Testing, Stability Testing, Product Changeover/Cleaning Testing, Environmental Monitoring
2. Appointment and coaching of Process Manager
3. Definition and maintenance of process agreements
4. Coordinating of the cross-departmental interfaces
5. Deciding on and implementing improvement measures
6. Oversight of all Customer Project relevant responsibilities and tasks within the QC department
QUALIFICATIONS
Master’s degree with 6+ years of industry experience, or PhD with 4+ years of industry experience. Equivalent education and experience may substitute for stated requirements.
Strong knowledge of quality control standards, methodologies, and best practices.
In-depth knowledge of Good Manufacturing Practices (GMP) and their application in the industry.
Experience with quality management systems (QMS)
Excellent analytical and problem-solving skills
Strong leadership and team management abilities
Exceptional communication and interpersonal skills
Ability to work effectively under pressure and meet tight deadlines
Proficiency in using quality control software and tools
Strong verbal and written communication skills in German and English language
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
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AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.
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