Quality Compliance Lead

Responsible for managing and implementing quality compliance programs and measures to ensure AbbVie medicines and ingredients are safe effective and of appropriate quality. Initiates and leads high impact global cross-functional projects as response to complex large scale external compliance standard updates and changes. Benchmarks and participates in industry interest organizations representing AbbVies interests and influences regulation modification and establishment when possible.

Responsibilities:

Owns external compliance standard updates from identification of the change through assessment and implementation for assigned scope

Manages the assessment and implementation of compliance related changes according to official timelines acting as the event owner in the corporate Quality Management System

Actively follows up with Subject Matter Experts (SMEs) such as QA and R&D site contacts as well as Quality COE leads to ensure the implementation of changes are completed in a timely manner including initiating the Document Change Control (DCC) process and updating impacted documents

Provides interpretation quality compliance standards to functional areas such as Regulatory QA R&D Manufacturing

Leads the generation of metrics to monitor the performance of compliance

Leads complex cross-functional initiatives or projects to address or implement compliance

Proactively represents AbbVies interests with applicable external industry interest groups and organizations

Serves as the AbbVie point of contact for external parties related to compliance and communicates to them any comments questions or issues from internal SMEs. Leads alignment activities between external and internal stakeholders.

Qualifications :

• Bachelors Degree in Chemistry Pharmacy Biology Microbiology Engineering or other technical/scientific area required
• 6 years in quality assurance and/or quality system oversight required.
• Experienced in the use of standard software applications including Office 365
• Strong interpersonal verbal and written communication skills effective facilitation and collaboration with stakeholders (including sites or cross-functional teams)
• High level of competence confidence and credibility for interaction with stakeholders
• Proficient organization planning and project management skills
• Ability to demonstrate high level of independence and decision making anticipate program scope and deliverable changes and effectively communicate issues with management
• Strong analytical skillsets detailed and quality oriented and with great judgment and integrity
• Ability to provide strategic direction and support for problem solving
• Must demonstrate effective performance to prevent legal or regulatory vulnerabilities which would result in product recall or governmental seizure for lack of compliance to requirements

Additional Information :

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. 

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time