QA Compliance Specialist - 12 month contract
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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
The NPI Compliance Specialist is responsible for ensuring new products transferred to AbbVie Sligo are manufactured in accordance with applicable regulatory requirements and AbbVie procedures and policies. To ensure effective and compliant transfer of New Products to the site.
Responsibilities:
Responsible for maintaining the effectiveness of the integration of new products into the AbbVie NPI quality system.
Ensuring that new products manufactured at AbbVie Ireland NL B.V. meet requirements of applicable regulatory requirements and AbbVie procedures and policies.
NPI Compliance Specialist is responsible for supporting new product transfers to the site from development through to commercialization, liaising closely with local and external cross functional teams to provide direction on quality concerns and ensure appropriate mitigation to address potential risk.
Support vendor evaluation and approval, management of all technical agreements from initiation, review, approval, and storage.
Support review and approval of NPI related Analytical Test Method Transfers and / or validation.
Collaborate with CMC QA, R&D, S&T, and other functional groups to maintain roles and responsibilities, identify potential quality issues, obtain an understanding of the quality compliance and provide input on quality concerns.
Coordination of site review of new product related material specification documents including but not limited to, intermediate specifications, API specifications, Drug Product specifications, raw material specifications, and excipient specifications.
Support review and approval of new product related analytical Test Method Transfers and/or validation.
Support the management of new product related exception documentation including the generation of corrective and preventative action to prevent reoccurrence.
Generation of product transfer documentation to attest the completion of product transfer deliverables, in advance of the applicable product transfer stage gate review.
Interfaces with internal auditors and outside regulatory agencies/auditors as the subject matter expert for new products and technology transfers.
Adheres to and supports all EHS & E standards, procedures and policies
Qualifications
A Third level qualification in a science, quality or relevant discipline.
A minimum of three years’ experience in a quality role supporting new product introductions.
A strong knowledge of regulatory requirements is required
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 1008 comparable Quality roles across 131 biopharma companies.
Salary context
193 of 1008 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 1008 comparable roles
+ 42 more countries
Seniority mix
498 of 1008 peers have a known seniority level
Therapeutic area mix
2 of 1008 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
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How we calculate "similar"
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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.