About this opportunity
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.
Major 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/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
Job details
How this role compares
Computed from every other active Quality role in our database, not just this employer's listings.
We currently track 1523 comparable Quality roles across 149 biopharma companies.
Salary context
248 of 1523 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 1523 comparable roles
+ 47 more countries
Seniority mix
690 of 1523 peers have a known seniority level
Therapeutic area mix
1 of 1523 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
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How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.