Qualified Person Biotechnology Operations

Qualified Person Biotechnology Operations

Position Summary: The Qualified Person (QP) plays a pivotal role in ensuring the quality and regulatory compliance of our biopharmaceutical products within our next-generation manufacturing facility. This position is responsible for implementing and executing batch approval and regulatory authorization for the site. The Qualified Person will collaborate with various departments to support the technical agenda and serve as a technical mentor for the site quality assurance teams.

Key Responsibilities:

Batch Approval

• Ensures manufactured biotech drug substance (DS) batches are certified in accordance with all required regulations and in compliance with IND/CTAs/ manufacturing authorisation/ marketing authorisation.
• Ensure that biotech drug product batches are tested in compliance with manufacturing & marketing authorisations (BLA/MAAs/ROW CTDs).
• Is responsible for the final decision associated with batch certification.
• Ensures that the principles and guidelines of GMP as stated in 2003/94EC, 2001/83EC, 536/2014 (repealing 2001/20/EC), associated EU GMP annexes, (e.g., Annex 13, Annex 16) and current product specification file (PSF) are met.

Technical Leadership

• Provide Quality leadership, direction, training and governance for the specific area of responsibility.
• Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.
• Continue to maintain knowledge and experience in line with technical and scientific progress for product(s) of responsibility in alignment with Annex 16 requirements.
• Communication and education of personnel in GMP requirements and regulations.

Document Review/Approval

• Responsible for approving appropriate quality-related documents. An approval signature confirms that, GMP and relevant regulatory requirements have been met.
• As per the requirements of local procedures, review and approval of change controls, deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
• As per the requirements of local procedures, review and approval of GMP documents associated with qualification and validation including but not limited to change controls, IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data and periodic review reports (PRR) and annual product reviews (APR) product quality evaluations.
• As per the requirements of local procedures, review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
• Familiar with the contents of or else involved in the review/approval of the applicable Quality Agreements.

Quality Monitoring Programs

• Monitoring of GMP compliance and verification of the effective implementation of key GMP programs and systems by ensuring a regular presence in the area of responsibility.
• Monitoring of the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.

Regulatory Submission & RTQ Support

• Responsible for issuance of QP declarations where required.
• Understand the conditions and requirements when a renewed authorisation is necessary and ensure they are complied with.
• Evaluation and contribution of regulatory information to regulatory documents including review/approval of dossier sections as part of the product submission processes.

Basic Qualifications: 

• BSc, MSc, or PhD in Biology, Chemistry, Pharmacy, or related discipline.
• Must be approved by member state as a licensed QP in order to be named on the company licence as a QP.

Additional skills/experience: 

• Minimum of 10 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
• Strong understanding and working knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.
• Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.
• Demonstrated success in influencing without authority.
• Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership.
• Ability to communicate effectively with all levels and functions in the organisation.
• Ability to work on multiple concurrent project initiatives.
• Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.

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