Associate Director, Clinical Quality Assurance

The Associate Director Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility.

This role will ensure that R&D remains in compliance with the corporate policies and applicable worldwide regulations. The role assures inspection readiness within the scope of a Clinical Development program/system. Provide consistent and aligned consultation to R&D team members from multi-functional interactions and delivering a comprehensive QA perspective. Influencing the decision-making process to ensure quality requirements are included within improvement initiatives.

This position is accountable to the Director of Clinical Quality RDQA.  The decisions and recommendations made by the individual will directly impact adherence to applicable regulations and thereby promote the continued success of R&D.

Responsibilities:

• Lead collaboration across TAs to ensure best practices and lessons learned are applied both within their area of responsibility as well as across TAs.
• Lead cross-functional projects and strategies that directly benefit the programs in their Therapeutic Area and identify when cross-TA opportunities can be implemented.
• Monitor new regulations and industry trends.  Ensure Compliance with Regulations and Policies within AbbVie and in partnership with external collaborations as applicable.
• Identify and manage support of issues within their programs and escalate as appropriate.
• Deliver program plans to support Inspection Ready development programs
• Coordinate internal and external compliance actions assessments and audits that will impact their area and align support with Business Partners and QA partners
• Lead efforts to review critical clinical documents development approaches and engage with strategic business partners in support of a proactive CQA team with actionable understanding of the assets
• Lead Risk Management principles and establish strong sustainable connections across RDQA QA teams supporting assets in development proactively engaging across RDQA including by expanding connections to also include the business to deliver effective mitigation strategies to critical business partner networks.
• Leverage their comprehensive understanding of the programs and upcoming development milestones to build quality into development programs early prevent risks from impacting submissions and approvals while increasing success during GCP inspections. 
• Proactively identify monitor and ultimately improve the CQA organizations connections and utilization of critical Quality System Elements applying quality by design principles across Risk Management Change Management and Exception Management (inclusive of planned changes issues and exceptions).
• Engage stakeholders in on-going reviews of the activities issues and achievements and build forums to ensure QA inclusion for process improvements and team awareness of proactive QA activities.

This role can be based in Lake County IL/Irvine CA/ South San Francisco CA/ Worcester MA 

Qualifications :

• Bachelors degree in a physical science life science nursing pharmacy or equivalent technical experience required.
  10 years of pharmaceutical industry experience in any combination of quality assurance/regulatory affairs/clinical research development.
• Well-developed leadership skills
  Demonstrated application of critical thinking and the ability to independently develop and implement strategic quality solutions in support of clinical research development programs.
  The incumbent must be able to evaluate the quality of clinical operations outputs perform assessments to identify potential gaps and recommend mitigations.
• The incumbent must be agile and able to respond rapidly to unplanned events changing needs of development programs as well as changing regulatory requirements and expectations.
  Must be able to formulate decisions and approaches in the complex matrix world of clinical research and development with all associated business partners and functions. Strong understanding of local regulatory and legal requirements.
• Excellent communication (written and oral) influencing and persuasion skills matrix managing without direct authority and collaboration/negotiation for mutually beneficial outcomes.

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