Senior Manager, Clinical Quality Assurance

BioSpace; North Chicago (IL); On-site; USD 120,000 - 155,000; Full time

Job summary

AbbVie is seeking a Senior GCP Quality role to lead quality activities across one or more clinical programs, driving proactive management and ensuring regulatory compliance. You will influence the Comprehensive Quality Strategy, perform audits, and oversee health authority interactions as the primary program liaison.

The role requires a Bachelor’s degree in a physical or life science and 5+ years in GCP QA or related fields, with strong leadership, strategic planning, and global regulatory

Qualifications

• Bachelor's degree in a physical or life science, nursing, pharmacy or equivalent experience.
• 5+ years of pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development or clinical operations.
• Proven leadership experience and ability to drive results and meet expectations.
• Strong problem solving and issue-resolution skills across global regulatory environments.
• Strategic planning and cross-functional execution experience in clinical development.
• Understanding of global pharma regulatory environments and RDQA functions.
• Experience preparing and presenting key information to stakeholders.

Responsibilities

• Develop and manage timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including risk and issue management.
• Design an audit program with internal and external audits to ensure inspection readiness.
• Interpret and apply current governmental regulations and guidelines to study protocols and activities.
• Prioritize activities to meet study/program objectives.
• Interact with Development Operations to ensure quality compliance across clinical development; mitigate quality risks.
• Provide program leadership in quality across clinical development functions.

Skills

Leadership

Problem solving

Strategic planning

Cross-functional collaboration

Regulatory compliance

GCP QA

Project management

Education

Bachelor's degree in physical or life sciences

Job description

About AbbVie

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

AbbVie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Purpose

Job Description

Primarily responsible for leading the management of GCP quality activities in support of studies and projects across one or more clinical programs to drive proactive quality management, and ensure compliance with corporate policies and functional procedures and applicable global regulations.

As the primary GCP quality interface cross-functionally in R&D for the product, this individual will influence and provide oversight of activities that include execution of the Comprehensive Quality Strategy game plan, informal surveillance, assessments as appropriate, design and execution of a fit for purpose audit program with the goal of submission-ready quality data, first pass approvals by health authorities for market authorizations, and bringing our compounds to our patients. This is an independent contributor role that will influence across matrix organizations.

Responsibilities

• Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including a lead role in Risk and Issue Management


• Assess the success and effectiveness of the quality system and assure inspection readiness by designing an audit program of internal and external compliance audits and applicable assessments


• Interpret, explain and apply applicable current governmental regulations, guidelines, policies and procedures to study protocols and associated activities


• Prioritize activities to ensure objectives of studies/programs are met


• Interact with Development Operations organization and supporting functions to ensure quality compliance across all aspects of clinical development; Identify and mitigate potential clinical quality risks and escalated to management; Leverage knowledge of clinical development to maintain program oversight and influence proactive quality management through quality related activities; Provide project/program leadership in quality as a team member across clinical development functions


• Anticipate, influence, and determine present and future business needs in support of quality for a drug development program


• Lead the effort to articulate and present an integrated cross-functional and comprehensive quality strategy plan


• Identify and implement balanced fit-for-purpose quality management; Develop and recommend strategies and tactics for success


• Identify and remove barriers that could impact program objectives, priorities, timelines, and quality. Communicate risks and mitigation to management


• Serve as the primary program quality liaison during health authority inspections

This role can be located in North Chicago, IL, Irvine, CA, South San Francisco, CA, Worcester, MA, Dublin, Ireland or Maidenhead, UK.

Qualifications

• Bachelors degree in a physical science, life science, nursing, pharmacy or equivalent experience required


• 5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations (oncology-specific a plus, but not a requirement). Prefer 1+ years of GCP QA auditing experience


• Successful and progressive leadership experience in motivating teams to anticipate and deliver strong operating results, as well as to meet or exceed customer expectations.


• Problem solving abilities required at both strategic and operational levels, ability to identify and resolve issues related to quality and compliance with global and local regulations, policies, and procedures. This involves both internal cross-functional problem solving as well as issue resolution between functional areas and external collaborators.


• Demonstrated ability in strategic planning and cross functional execution


• Proven track record utilizing core and technical competencies in managing projects in support of clinical research


• Strong understanding of global Pharma, clinical development and operations, legal and regulatory environments


• Experience in preparing/presenting key information


• Comprehensive knowledge of the interrelationship among other RDQA GXP functions and with business functions to serve as a good business partner

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal 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 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 employer remains in the Company's 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

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

https://www.abbvie.com/join-us/reasonable-accommodations.html