Head Quality Operations Biologics.

Job ID: 10901

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Discipline
Quality/Production
Type of employment
Festanstellung
Company

Our Client is a biopharma company with state-of-the-art facilities. Operating across international centers specialized in clinical manufacturing and commercial scale production. Our client provides expertise and facilities from cell line development over process development, API production to fill & finish for partners and in-house biological pipeline. The leading one stop shop for biologics from cell line development to drug product.

Responsibilities

General:

Develops, implements and supervises Quality Management System in area of direct manufacturing operations, production process related deviations, batch release, complaints' management, product withdrawals, and data integrity. Ensures proper implementation and maintenance of Standard Operating Procedures related to area of responsibility. Prepares Quality Operations Unit for pharmaceutical inspections and audits led by national and foreign authorities. Participates and represents Polpharma the client in internal and external audits. Leads and manages Quality Operations Team. Fulfillment of legal requirements according to which in a company manufacturing IMPs function of Qualified Person must be established.


Details:

  • Quality oversight over manufacturing operations performed at the client

  • Development, approval, implementation and monitoring of realization of Standard Operating Procedures and other systemic documents governing the area of direct responsibility, especially those referring to batch documentation review, batch release/rejection, data integrity, management of complaints. Approval of validation documentation

  • Verification of compliance of GMP documentation in area of responsibility with the internal and external applicable regulations before implementation. Maintenance and development of the Quality System in cooperation with Production Dept. and Head of Quality Unit. Ensuring compliance of Production with the QMS, GMP, EU, FDA and local requirements

  • Assurance that all investigations referring to deviations and complaints are performed properly, clarified (including root cause identification) and closed, according to proper procedures and law regulations

  • Assuring that all corrective and preventive actions are properly defined, planned, distributed and finalized in expected time

  • Participation in preparation and review of relevant technical/quality agreements

  • Performing internal and external audits

  • Ensuring review of all documentation generated within production processes including batch records, environmental monitoring, cleaning records, equipment parameters/log books, and process deviations is performed

  • Oversight with regard to activities of Quality Operations personnel

  • Performing all duties with respect to current GMP requirements and other pharmaceutical regulations

  • Representing the company /Quality Ops during regulatory inspections

  • Connected to the role of Qualified Person:

    • Review of batch records of drug substance, product in bulk, medicinal product and IMP, and confirmation of manufacturing stages

    • Release and rejection of drug substance, product in bulk, medicinal product or IMP

    • Participates in communication with the Sponsor or Product Owner, in the process of withhold and recall of the medicinal product or IMPs and in investigation following from product complaints

    • Making independent decisions about Medicinal Product batch
Requirements
  • Higher education in biology, chemistry, pharmacy, biotechnology or related

  • Min. 5 years of work experience in the pharmaceutical industry, including two years in the evaluation of pharmaceutical products

  • Fluent knowledge of English, both written and spoken

  • Excellent knowledge of GMP requirements and pharmaceutical laws and regulations related to medicinal products/investigational medicinal products, specifically in the ICH environment

  • Knowledge of the technologies of manufacturing sterile medicinal products and drug substances

  • Leadership skills. Ability to make decisions. Ability to work as a team player. Ability to lead Quality Operations team

  • Understanding of analytical techniques related to the evaluation of medicinal products

  • Broad knowledge of Quality Management Systems, in particular with regard to applying the system into manufacturing operations, leading investigations of deviations and their evaluation, and corrective/preventing actions as general tool in the areas
Benefits
  • An opportunity to build and shape an organization according to your ideas

  • Internationally competitive compensation & benefits
Region
Europa