Associate Director Quality, Microbial Contamination Control
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
Reporting to the Director of Sterility Assurance and Contamination Control, the Associate Director of Quality, Microbial Contamination Control is a pivotal role in providing quality oversight and leading improvement initiatives for sterility assurance and contamination control across AbbVie’s internal sites and external manufacturing network. The role ensures AbbVie processes and procedures meet current and emerging regulatory requirements and industry best practice for sterile drug and biological products manufactured by aseptic processing or terminal sterilization. This includes providing technical and quality assurance expertise, driving education and training, and identifying and mitigating potential risks to product quality across aseptic processing and sterile manufacturing operations.
Develop and implement comprehensive sterility assurance frameworks, including contamination control strategies aligned with Annex I and global GMP guidelines
Serves as a knowledgeable technical and quality resource for the AbbVie network with regards to contamination control and associated strategies.
Lead contamination control initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments
Provide Quality and Compliance guidance to the global Sterile and Bulk Drug substance sites supporting inspection readiness and sterility assurance
Provide AbbVie sites technical guidance for aseptic process simulation programs, air flow visualization studies, disinfection validation programs, and environmental monitoring programs
Lead Contamination Control assessments for aseptic processing steps identifying opportunities to improve site level contamination control strategies
Supports Site regulatory inspections and self-inspection programs
Provide aseptic subject matter expertise to external manufacturing quality assurance and act as subject matter expert for external manufacturing auditing program
Provide specialist technical and compliance guidance to manufacturing site event investigations
Provide aseptic development and mentoring to sites and functional groups
Assess the AbbVie Quality System for revision in compliance with applicable regulatory requirements and alignment with regulatory expectations
Member of AbbVie’s Centers of Excellence for Contamination Control and Microbiology laboratories
Provide quality and compliance guidance to the sites for the development of environmental monitoring programs and trending processes to ensure the capturing of and assessment of critical data pertaining to microbial control at a level commensurate with the product and process risk.
Qualifications
Bachelor/Master Degree in Microbiology and/or suitable science qualification
Minimum 7-10 years relevant experience and aseptic process knowledge within Pharmaceutical and/or Biopharmaceutical industry
Knowledge of Pharmaceutical Regulatory Requirements and expectations including Code of Federal Regulations, EU GMPs, EMA /FDA Guidelines, Pharmacopeia, PIC/S
Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve
Proven history of implementing innovative approaches
Demonstrated ability to effectively interface with multiple regulatory agencies
Ability to evaluate quality, production and support areas for compliance with Good Manufacturing Practices (GMP).
Excellent Communication skills both verbally 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 451 comparable Associate Director Quality roles across 90 biopharma companies.
Salary context
86 of 451 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 451 comparable roles
+ 34 more countries
Seniority mix
451 of 451 peers have a known seniority level
Therapeutic area mix
1 of 451 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.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Quality job in Ireland, and choose locations and companies.
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.