Associate Director - Qa It Audit Leader

Our Business Technology Solutions (BTS) team shapes the digital transformation accelerating the future of medicine at AbbVie-and we do it together, asking bold questions and taking on tough challenges through deep, honest collaboration. In the role of QA IT Audit Leader, you will join a diverse, global team that invests in your customized career growth and uses technology and data to positively impact people's lives.

The Associate Director, QA IT Audit is responsible for providing direction in quality assurance software auditing activities including: implementing both the Supplier and Internal IT Audit programs, reviewing Master Service Agreements; writing and reviewing audit plans and audit reports; and updating departmental procedures. This role will support the strategic direction to ensure business objectives are met. This position ensures that defined software auditing practices and procedures are being followed.

Responsibilities

• Lead the software quality auditing program for applications supporting  pharmaceutical products, medical devices, combination products and biologics.
• Oversees support to auditors for both GxP IT internal and GxP IT supplier audits.
• Ensure software quality assurance is achieved during IT projects while meeting project objectives and deliverables; audit validation deliverables to ensure consistency with defined practices and procedures.
• Manage all IT audit and supplier quality audit activities such as creating both the internal and supplier audit schedules, writing audit plans and reports, reviewing Master Services Agreements, and reviewing and approving audit responses.
• Responsible for implementing Quality Control standards into departmental documents and ensuring all departmental training is complete.
• Provide corporate-wide support in the establishment of software quality auditing and compliance practices.
• Manage the integration of new validation technologies and quality assurance practices into company-wide computing environment.
• Interface directly with FDA and other regulatory agencies during audits.
• Initiate process improvements to reduce GxP IT supplier onboarding costs and cycle time.

#LI-REMOTE

• Bachelor's Degree with 9 yrs experience; or Masters Degree with 8 yrs experience; or PhD with 4 years experience.
• Experience in GxP auditing, validation, systems testing, IT implementation, quality assurance or software quality engineering in a regulated healthcare industry.
• Technical experience in as many of the following areas as possible: Chemistry, Pharmacy, Microbiology, Engineering and Computer Science. This should include a thorough technical knowledge of various aspects of the business including Quality Control/Assurance, GMP regulations, and new product development.
• 2 years combined experience in GxP auditing required.
• ASQ certification as a Certified Quality Auditor is preferred.

Why Business Technology Solutions

For anyone who wants to use technology and data to make a difference in people's lives, shape the digital transformation of a leading biopharmaceutical company, and secure sustainable career growth within a diverse, global team: we're ready for you.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.  This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.