Associate Director, Clinical Quality Assurance
AbbVie
1 month ago
Remote friendly (Worcester, MA)
United States
Clinical Research and Development
The Associate Director, Clinical QA is responsible for developing and implementing a strategy for proactive quality oversight of clinical development programs within their responsibility. Ensures R&D compliance with corporate policies and applicable worldwide regulations, including inspection readiness. Provides consistent, aligned QA consultation to R&D teams and influences decision-making to include quality requirements in improvement initiatives.
Responsibilities:
- Lead collaboration across therapeutic areas (TAs) to apply best practices and lessons learned within and across TAs.
- Lead cross-functional projects and strategies benefiting programs in their Therapeutic Area and identify cross-TA opportunities.
- Monitor new regulations and industry trends; ensure compliance with AbbVie regulations and policies and applicable external collaborations.
- Identify, manage, and escalate issues within programs as appropriate.
- Deliver program plans to support Inspection Ready development programs.
- Coordinate internal and external compliance actions, assessments, and audits; align support with Business Partners and QA partners.
- Review critical clinical documents and development approaches; engage strategic business partners to support proactive CQA with actionable understanding of assets.
- Lead Risk Management principles; build sustainable connections across RDQA QA teams and proactively engage the business to deliver effective mitigation strategies.
- Apply quality by design principles across Risk Management, Change Management, and Exception Management to prevent risks from impacting submissions/approvals and improve GCP inspection success.
- Proactively identify, monitor, and improve CQA connections and utilization of Quality System Elements.
- Engage stakeholders in ongoing reviews and build forums to ensure QA inclusion for process improvements and proactive QA awareness.
Qualifications:
- Bachelor’s 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.
- Strong leadership and critical thinking; ability to independently develop and implement strategic quality solutions, assess clinical operations outputs, identify gaps, and recommend mitigations.
- Agile; ability to respond rapidly to unplanned events and changing regulatory requirements; strong understanding of local regulatory and legal requirements.
- Excellent written/oral communication, influencing and persuasion, matrix management without direct authority, and collaboration/negotiation for outcomes.
Benefits (as stated): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) to eligible employees; eligible for short-term incentive programs.
Location: Lake County, IL; Irvine, CA; South San Francisco, CA; Worcester, MA; Maidenhead, UK; Dublin, Ireland.
Responsibilities:
- Lead collaboration across therapeutic areas (TAs) to apply best practices and lessons learned within and across TAs.
- Lead cross-functional projects and strategies benefiting programs in their Therapeutic Area and identify cross-TA opportunities.
- Monitor new regulations and industry trends; ensure compliance with AbbVie regulations and policies and applicable external collaborations.
- Identify, manage, and escalate issues within programs as appropriate.
- Deliver program plans to support Inspection Ready development programs.
- Coordinate internal and external compliance actions, assessments, and audits; align support with Business Partners and QA partners.
- Review critical clinical documents and development approaches; engage strategic business partners to support proactive CQA with actionable understanding of assets.
- Lead Risk Management principles; build sustainable connections across RDQA QA teams and proactively engage the business to deliver effective mitigation strategies.
- Apply quality by design principles across Risk Management, Change Management, and Exception Management to prevent risks from impacting submissions/approvals and improve GCP inspection success.
- Proactively identify, monitor, and improve CQA connections and utilization of Quality System Elements.
- Engage stakeholders in ongoing reviews and build forums to ensure QA inclusion for process improvements and proactive QA awareness.
Qualifications:
- Bachelor’s 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.
- Strong leadership and critical thinking; ability to independently develop and implement strategic quality solutions, assess clinical operations outputs, identify gaps, and recommend mitigations.
- Agile; ability to respond rapidly to unplanned events and changing regulatory requirements; strong understanding of local regulatory and legal requirements.
- Excellent written/oral communication, influencing and persuasion, matrix management without direct authority, and collaboration/negotiation for outcomes.
Benefits (as stated): Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) to eligible employees; eligible for short-term incentive programs.
Location: Lake County, IL; Irvine, CA; South San Francisco, CA; Worcester, MA; Maidenhead, UK; Dublin, Ireland.