Objectives:

The Quality Operations Specialist is responsible for day-to-day quality operations activities by supporting manufacturing being on the floor during both Drug Substance (DS) and Drug Product (DP) manufacturing at a scale appropriate for clinical trial stage R&D/CMC development operations and GMP manufacturing operations.

The incumbent provides quality oversight on manufacturing batch record review and approval, manufacturing lot disposition, review and approval of site-specific procedures and GMP documentation, quality walkthroughs of GMP areas and review of deviation, CAPA and change control in accordance with Hilleman Quality Policy, Standards and SOPs. Ensure timely and accurate delivery of disposition requirements for reliable release of quality products.

Responsibilities:

• Provide front line day-to-day quality support on product quality issues to ensure GMP, regulatory, and procedural compliance and maintain standard of quality to ensure root cause and preventive measures are identified and corrective action are implemented.
• Assure timely review of manufacturing batch records, QC testing, change controls, deviations, complaints, environmental monitoring results and CAPAs associated to drug product for manufacturing lot disposition.
• Assure product quality and compliance by enforcing quality policies and procedures to ensure that the required processes, procedures and systems are adequately in place to enable compliant disposition of drug products.
• Collaborate with cross-functional stakeholders to ensure robust deviation investigation. Participate and approve deviation by performing root cause analysis to enable effective and timely closure of deviation, and mitigating action are identified and implemented.
• Review and approve SOP, quality risk assessment (QRA) and quality plan related to manufacturing operations.
• Provide support for quality technical review/approval of department related procedural changes.
• Lead and participate quality risk assessment (QRA) initiatives in close collaboration with internal and external stakeholders.
• Quality oversight for equipment life-cycle qualification and validation activities
• In collaboration with internal and external stakeholders to provide quality oversight for product / process scale-up and tech transfer activities including development of manufacturing batch records, product / process specifications, approval of analytical method verification / validation, release testing and stability of DS and DP.
• Lead and participate in continuous improvement initiatives and projects, ensure a focus on increasing both efficiency and quality out from all processes used by all cross-functional stakeholders.
• Support quality review of regulatory documents.
• Support site and functional team during regulatory inspection or audit.

Education, Behavioural Competencies And Skills:

Basic Qualifications:

• Bachelor’s Degree or Diploma, preferably in science, engineering or other related technical field.
• Minimum of 5-7 years of relevant experience in providing quality operations oversight of GMP operations at DS / DP facilities (preferably vaccines or biologics industry).
• Prior experience in facility start-up and tech transfer activities.
• Familiarity with regulatory requirements and local codes & standards especially in vaccines and biologics (e.g., FDA, EMEA, and ICHQ7).
• Excellent working knowledge and experience with the practical implementation of FDA, EMA, and ICH regulations and guidelines.



Preferred Key Skills, Abilities, and Competencies:

• Detailed GMP process and facility knowledge, and frequent shop floor presence.
• Experience with using risk-based approach and principles for decision making to ensure compliance at all stages of clinical trial product development and manufacturing.
• Experienced in supporting regulatory agency interactions such as regulatory submissions, pre-approval inspections, and observational response plans.
• Good verbal and written communication skills; effective communication and presentation skills across different levels of the organization, including senior management.
• Ability to coordinate actions with multi-functions to ensure that the overall Hilleman quality requirements are met.
• Experience in working with internal and external multifunctional teams.
• Partner and influence other departments and functions throughout the organizations to implement ongoing product / process robustness to continuously improvement.