Associate Director, Quality Toxins Office

Hiring By - Biostaffic

 BioPharma

Irvine, California - United States

Job Highlights

Not Disclosed

Director

Posted 4 months ago
Job details
AbbVie is dedicated to delivering a consistent stream of innovative, safe, and effective quality medicines and products that solve serious health issues and have a remarkable impact on people’s lives. As a quality organization in research & development, R&D Quality Assurance (RDQA) is committed to driving quality excellence across all stages of discovery and development for a product’s lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.
The Quality Toxins Office (QTO) provides compliance strategy, design, implementation, and continuous improvement to support toxin strategy across Therapeutics and Aesthetics. The QTO assures robust global compliance programs to assure quality oversight, controls, and compliance across applicable sites in the AbbVie global network.
The Associate Director, Quality Toxins Office, will lead the strategic direction of the QTO and drive implementation of an enterprise-wide toxin compliance framework. This individual will identify risk mitigations, lead projects, and engage with global and site stakeholders to drive continuous improvement related to biosecurity and biosafety by applying a strong understanding of toxin science, regulatory requirements, and internal AbbVie policies.
The role reports directly to the Head of QTO within RDQA.
Responsibilities
  • Develop a sustainable and collaborative relationship with R&D business functions in implementing toxin inventory controls and process improvements to assure regulatory compliance and internal policy obligations.
  • Design and deliver implementation and application of toxin policy requirements through creation of process and procedure documents supporting AbbVie’s global toxin network and enterprise toxin policy.
  • Independently evaluate potential quality risks and drive identification, mitigation, and prevention; facilitate and drive vision for continued process improvement.
  • Establish and lead quality compliance strategic initiatives across toxin network by developing process improvements, solutions, and guidance to mitigate safety and compliance risks, and in support of AbbVie’s R&D neurotoxin pipeline; establish and maintain QTO procedural documents.
  • Applies critical thinking in connecting concepts and strong negotiation to ensure overall quality compliance within and across the complex landscape of toxin work and design/implement fit for purpose solutions to address quality risks and issues.
  • Provide guidance to Responsible Officials/Alternate Responsible Officials, Principal Investigators, and key stakeholders to ensure compliance with regulations, guidelines, and company policies; design and implement governance, oversight, control processes, and procedures. Review/approve Form 3 reporting associated Corrective Actions and Preventative Actions (CAPAs), and related regulatory agency correspondence.
  • Develop adequate and timely escalation processes/workflows of reportable events and related safety and compliance risks including investigation, containment, solution, and preventive measures for quality issue escalations pertaining to Select Agents and Toxins (SAT).
  • Develop and manage project timelines and deliverables in support of RDQA and Pharmacovigilance & Patient Safety, Epidemiology and R&D Quality Assurance’s (PSEQ) strategic priorities.
  • Establishes relationships with global RDQA colleagues to ensure QTO activities are in line with global business priorities.
  • Support Centers for Disease Control (CDC) inspections of AbbVie’s SAT program, as needed.
Qualifications
  • Bachelor’s Degree or equivalent in related science field.
  • 8+ years pharmaceutical industry experience, including a minimum of 5+ years working with SAT with proven knowledge and understanding of toxin process and systems (preferably with a focused quality control/compliance role).
  • Regulatory expertise and extensive knowledge relating to toxin research with ability to strategically interpret and communicate requirements.
  • Demonstrated application of critical thinking and the ability to independently develop and implement strategic quality solutions in support of compliance principles for toxin research.
  • Successful and progressive leadership of projects and/or teams and in cross functional execution.
  • Experienced in CDC inspections and/or internal or third-party audits.
  • Excellent written and oral communication skills, project management, influencing and persuasion skills, matrix managing without direct authority, and collaboration/negotiation for mutually beneficial outcomes.
  • Ability to travel as needed (up to 25%)
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.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Location:

  • Irvine, California - United States

Experience:

  • Director

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
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