Supervisor, Quality Operations (Biologics)

• Supervise a team of Quality Operations Specialists to ensure that incoming material release, QC, warehouse and production at AbbVie Operations Singapore is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions approved by AbbVie Operations Singapore.
• Lead and act as Subject Matter Expert in change management to ensure system effectiveness and efficiency.
• Lead the team to perform review/audit of incoming material inspection package which includes receiving, sampling and testing compliance.
• Oversee and perform the timely of review of batch records of incoming materials, API/BDS for full compliance to written procedures prior to approval and release.
• Ensure that all quality goals/metrics are met, and all practices and procedures comply with AbbVie policies and applicable regulations for the Quality areas under his /her responsibility.
• Review and approve investigations and CAPA actions to assess level of consistency and
• compliance among plant department's investigations.
• Ensure investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Perform product impact analyses for plant events and place incoming material and/or product on QA Hold where appropriate.
• Responsible for Annual Product Quality Review and Product Quality Assurance
• Lead/liaise with other departments for cross-functional issues and/or projects/initiatives for continuous improvement by maintaining an effective liaison and cooperative relationship with other stakeholders.
• Maintain performance measurements of the Change management, incoming material release, batch record review and product release processes to enable the continuous improvement cycle.
• Proactively participate and support new product introduction, operation excellence projects assigned by management as appropriate.

• Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Pharmacy, or Engineering.
• Master Degree desired but not required.

• Quality/compliance management skills. This position requires knowledge of quality / compliance management as well as regulations and standards affecting APIs /Biologics.
• Minimum of 8+ years of pharmaceutical, biopharmaceutical experience in Quality and/or
• Compliance (GxP) environment.

• Ability to quickly know products and processes in order to assess quality issues
• Total commitment to quality and maintain a high standard of work at all times
• Demonstrates the highest levels of integrity and a strong work ethic
• Good knowledge of GxP requirements and regulations
• Good level of decision making and problem solving
• Good planning and scheduling skills
• Good communication skills both verbal and written
• Good interpersonal skills

AbbVie