Senior / Quality Operations Supervisor (Bio)

Allergan; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AbbVie Operations Singapore seeks an experienced Quality Operations leader to supervise a team ensuring cGMP compliance across QA, manufacturing, and related functions. You will drive batch release, investigations, and change control while coordinating with global Quality Centers of Excellence.

The role requires 8+ years in GxP environments and 2+ years of people management, with strong written and verbal communication skills to interface with auditors and internal stakeholders.

Qualifications

• 8+ years of experience in a GxP environment and Quality Operations.
• 2+ years of people management experience.
• Strong knowledge of quality/compliance management for APIs/Biologics.
• Ability to quickly understand products and processes to assess quality issues.
• High integrity and strong work ethic; commitment to quality.
• Solid knowledge of GxP requirements and regulations.
• Excellent verbal and written communication skills.

Responsibilities

• Supervise routine activities (batch review, release, walkthrough, tag-out) independently.
• Lead training for batch release and MES review; guide colleagues across disciplines and front auditors.
• Identify and resolve technical/operational problems; collaborate with peers and cross-site teams to resolve issues.
• Lead or support cross-functional projects; present updates to management.
• Review and approve SOPs; ensure compliance with local procedures.
• Support investigations of non-conformances; perform root cause analysis and CAPA.
• Manage change plans and PQR reports; ensure lifecycle completion per CP framework.
• Mentor direct reports and develop team capabilities.
• Oversee batch record reviews for API/BDS; ensure timely disposition and QA release.
• Lead New Product Introductions (Quality) and product changeover activities.

Skills

GxP knowledge

People management

Quality compliance

Decision making

Communication skills

Education

Bachelor's degree in Sciences/Pharmacy/Engineering

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:

• Local: Supervise a team of Quality Operations specialists to maintain the Quality systems that are in place for Site Operations in accordance to AbbVie Policies and cGMP. Supports the development and implementation of Quality systems for Site Operations in accordance to AbbVie Policies and cGMP. SME for 3-4 cGMP, QO systems. Puts a system in place that ensures team support of routine business operations support 24/7. Provide quality oversight for Warehouse, QC, Manufacturing, Engineering (facilities) and IT. Responsible for change management and batch record review and release. Ensure high quality execution and NPI has no impact to routine operations.
• Global: Participates in Quality COE. Works with global counterparts to ensure cross-site Operations remain compliant with AbbVie Policies and cGMP
• OE: Participates in cross functional team to achieve site objectives. Promotes initiatives to streamline Quality systems. Coaches Specialists on cGMP and QO systems. Supervises Specialists to achieve site goals / metrics. Mentors Interns and Associates to assimilate into the Quality Culture

Key Responsibilities:

Routine Activities

• Supervises all routine activities (batch review, release, walkthrough and tag-out) independently. Able to develop/review quality operations procedures.
• Supervise training for batch release and/or MES review, able to guide colleagues across multiple disciplines and able to front auditors
• Able to identify and resolve technical and operational problems; collaborates with peers/managers/directors to resolve (more complex/urgent) problems that cross into inter-related units / inter sites independently, meeting internal and inter-sites metrics and timeline.
• Lead/Support teams or projects independently (cross functional/large group); promotes value of working together as a team and relationship building, using the diverse perspectives of others to generate ideas and implement solutions to drive results and performance. Presents project updates to management.
• Review and approve SOPs of stakeholders (local) independently
• Support in investigation arising out of products or manufacturing processes non-compliance to perform product impact assessment, root cause analysis and to ensure effective corrective action and preventive actions to prevent recurrence (Lead/manage multiple low/med impact NCRs impacting MFG continuity).
• Strong processproduct and process knowledge to support complex Change plan review, track and trend review and PQR report generation/ review. Ensure change plan lifecycle is managed and delivered per CP framework.
• Mentors direct reportswhen they face challenges and help to identify areas for development.
• Able to present technical and operational issues with proposed solutions to higher management (more complex, independently)
• Oversee the review of batch records of API/BDS for full compliance to written procedures prior to approval and release. Ensure timely disposition of API/BDS in the system and perform the QA disposition for API/BDS batches.
• Lead New Product Introduction (Quality), product changeover and associated process FMEA updates.
• Primary contact as site change coordinator and liaison with global change coordinator to ensure all the global change proposal is managed and administrated in according to the procedure.
• Supervise Annual Product Quality Review and Product Quality Assurance.

Supervisory Responsibilities

• Supervise a team of Quality Operations Specialists to ensure that 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.
• Mentorssubordinates when they face challenges. Identify areas/opportunities for development for subordinates and to meet business needs.
• Manages, coordinates and supervises the daily activities of quality operations team
• 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.
• Maintain an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Demonstrate accountability and responsibility of EHS performance and compliance.

Continuous Improvement

• Able to interpret internal/external business challenges and best practices to recommend improvements to processes.
• Lead/liaise with other departments for cross-functional issues and/or projects/initiatives for continuous improvement
• Maintain an effective liaison and cooperative relationship with other Quality areas and Plant departments.
• Demonstrate accountability and responsibility of EHS performance and compliance.

Qualifications

Education

• BachelorÃÂâÃÂÃÂÃÂÃÂs degree in Sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or related Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• 8+ years of relevant work experience in (GxP) environment and prior Quality Operations function is required.
• 2+ years of people management experience.
• Strong knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics.
• Demonstrated quality / compliance management skills.
• Demonstrated ability to quickly know products and processes to assess quality issues.
• Strong total commitment to quality and maintaining a high standard of work.
• Demonstratedhighest levels of integrity and a strong work ethic.
• Solid 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.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html