Quality Operations Supervisor (API)

AbbVie; Singapore; Vor Ort; SGD 90.000 - 140.000; Vollzeit

Zusammenfassung

AbbVie Singapore is seeking a senior QA/QUALITY OPS leader to supervise a team responsible for API manufacturing quality systems and 24/7 operations support. You will oversee batch release, change control, NCRs, and investigations while ensuring cGMP adherence and collaboration with global teams.

The role requires a strong background in GxP, quality compliance, and leadership, delivering high-quality results and mentoring colleagues to meet site goals.

Qualifikationen

• Knowledge of quality / compliance management and regulations affecting API.
• Total commitment to quality and integrity.
• Strong planning, scheduling, and communication skills.

Aufgaben

• Supervise Quality Operations Specialists to ensure API manufacturing compliance.
• Oversee batch review, release, and change management with cross-site coordination.
• Mentor staff, lead investigations, and drive continuous improvement initiatives.

Kenntnisse

Quality / Compliance

GxP knowledge

Decision making

Problem solving

Planning & scheduling

Verbal & written communication

Ausbildung

Bachelor's degree in sciences or engineering

6+ years GxP experience

Jobbeschreibung

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.

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 API Quality Operations specialists to maintain AbbVie Quality Systems that are in place for API Manufacturing Operations in accordance to AbbVie Policies and cGMP. Monitors that Site Operations comply with AbbVie Policies and cGMP. Ensure team support of routine business operations support 24/7. Provide quality oversight for API Warehouse, QC, API Manufacturing, Engineering 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. Supervise and mentor Specialists to achieve site goals / metrics. Mentors Interns and Associates to assimilate into the Quality Culture.

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/supervisors/managers to resolve problems that cross into inter-related units independently, meeting internal metrics
• 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.
• 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).
• Process product and process knowledge to support Change plan review, track and trend review and PQR report generation/ review. Ensure change plan lifecycle is managed and delivered per CP framework.
• To mentor reportees when 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.
• Any other responsibilities or tasks as assigned by your Supervisor/Manager

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.
• To mentor subordinates 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

• Bachelor’s degree in sciences (i.e. Biologicals, Biomedical, Chemistry, Life Sciences, Pharmaceutical), Pharmacy, or Engineering (i.e. Biomedical, Chemical, Pharmaceutical), or equivalent
• A minimum of 6 years of relevant work experience in (GxP) environment and Quality function is required.
• Proven track record of team work

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

• This position requires knowledge of quality / compliance management as well as regulations and standards affecting API.
• Quality / Compliance management skills.
• Ability to quickly know products and processes to assess quality issues.
• Total commitment to quality and maintaining a high standard of work.
• Demonstrates the highest 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