Director, Safety. Regulatory Affairs and Medical Affairs Quality Standards (Hybrid)

Company: Initial Therapeutics, Inc.
Location: Irvine
Posted on: March 6, 2025

Job Description:

Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, and eye care, as well as products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , and .Job DescriptionPurpose: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 the product lifecycle to achieve product realization and accelerate access to innovative therapies and products for our patients.AbbVie's quality foundation resides in the Quality Policy and Quality System as an integrated model in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements.The Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfolio.The role oversees generation and assessment of current/new safety, regulatory and medical affairs policies and procedures to ensure that they meet and/or exceed expectations. Serves as thought leader/expert in R&D Quality Assurance strategic GxP function process updates, proactively assesses evolving regulatory changes. Generates new approaches to advance quality assurance excellence mindset.The role reports to the Senior Director of Safety, Vigilance and Medical Affairs Quality Assurance. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization.Responsibilities:

• In collaboration with applicable GXP RDQA Leaders, lead, develop and implement routine and QA oversight strategies relating to R&D business stakeholders including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs to ensure optimal QA oversight and continuous improvement.
• In collaboration with other RDQA Quality Standards Leads implement process to lead gap assessments of draft and final regulatory intelligence against internal core requirements and SOPs. Ensures effective safety, regulatory and medical affairs Management Review process. Drives continuous improvement through the R&D Quality Plan process.
• Oversees the development/implementation of safety, regulatory and medical affairs corporate and/or organizational policies/procedures. Partners with the Director, R&D Quality Assurance on cross-GxP standards and those requiring RDQA Leadership support.
• In conjunction with Compliance leaders, review escalation issues to proactively identify emerging trends, including developing and implementing appropriate action plans to ensure strategic continuous improvement and ongoing compliance.
• Represents safety, regulatory affairs, and medical affairs in the Quality System Owner Network Governance Structure. Seeks opportunities for simplification and efficiency.
• In collaboration with functional QA Leads is responsible for the discovery, evaluation, and potential implementation of safety, regulatory and medical affairs function regulatory requirements. Proactively monitor and interpret the external global regulatory environment for regulatory issues, trends, and changes that have the potential to impact our products.
• Consistently demonstrate AbbVie's Ways of Working and Leadership Attributes including a collaborative mindset and people leadership. Effectively manage performance inclusively and equitably; provide timely feedback, appropriately reward, and recognize valuable achievement, develop talent and create a succession pipeline. Create a learning environment, embrace the ideas of others and manage innovation to reality.
• Establish high expectations and goals to ensure organizational success and lead staff to meet or exceed those expectations. Encourage a culture of open and honest communication where all are encouraged to express their views, offer suggestions and experiment for improvement.Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.Frequent to continuous computer usage (greater or equal to 50% of the workday) is required.QualificationsQualifications:
  • Bachelor's degree preferably in Life Sciences, Biology, Nursing, Pharmacy, or other science-based degree.
  • Minimum of 10 years pharmaceutical experience, including substantial, progressive leadership positions in quality and/or compliance.
  • Proven leadership skills with direct reporting and matrixed environments. Well-developed leadership competencies including motivation, cultural awareness, active engagement, relationship building, sound judgment, and the management of sensitive proprietary information.
  • Extensive knowledge of quality standards, worldwide regulatory requirements and industry best practices relating to Safety, Regulatory Affairs and/or Medical Affairs and experience in interpretation and application of quality assurance/controls of regulatory requirements.
  • Strong, strategic, creative, and "big picture" thinker, considered a visionary. Proactive leader with well-developed management skills and the ability to anticipate and identify potential issues to address early to mitigate or prevent. Demonstrated executive presence. Ability to make difficult decisions under pressure.
  • Flexibility to adapt to changing assignments and ability to effectively prioritize with minimal supervision. Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner.
  • Excellent communication skills, including superior negotiation and influencing skills. Acute listening skills to gain understanding or to solve a problem and the ability to recognize the difference. Ability to manage difficult conversations and seek alignment. Ability to motivate and develop high-performing teams with challenging goals that bring growth and development, including those over whom they have no direct authority.Additional InformationApplicable 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 an equal opportunity employer and 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.US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
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Keywords: Initial Therapeutics, Inc., Irvine , Director, Safety. Regulatory Affairs and Medical Affairs Quality Standards (Hybrid), Healthcare , Irvine, California