Head of Quality Control

Vor 2 Tagen

Heidelberg, Deutschland AGC Biologics Vollzeit

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

According to AMWHV -12 and -14 the Head of Quality Control is responsibilities for:

- Acceptance or rejection of starting materials, packaging materials and intermediate products
- Approving specifications, sampling instructions, and testing instructions in accordance with -14 Section 1 and ensuring that they are followed,
- Ensure that all required testing has been performed,
- Approval of the commissioning as well as supervision of the analytical laboratories acting on behalf,
- Control of maintenance, facilities and equipment for the performance of tests,
- Ensuring that the necessary validations of the test procedures are carried out, and
- Ensure required initial and ongoing training of personnel working in the field of testing.

Management
- 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
- Implementation and monitoring annual AGC objectives (people, quality, processes, growth, finance, customer) with regards to QC
- Responsibility for CAPEX (incl. System implementations) projects within the QC

Human resources
- Professional and disciplinary management of subordinate positions
- Conducting regular meetings with subordinate positions and ensure that subordinates hold regular meetings with their direct reports in this regard
- Coordinate Staffing with Head of Quality
- Initiation of QC specific training and development measures

Processes
- Process responsibility incl. KPls 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
- Appointment and coaching of Process Manager
- Definition and maintenance of process agreements
- Coordinating of the cross-departmental interfaces
- Deciding on and implementing improvement measures
- 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.-
- 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._
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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._

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