Associate Director, QA

BioSpace; North Chicago (IL); On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie seeks a leader to head a team of Clinical Auditors across the Americas, shaping strategy and assuring compliance in clinical development.

You will drive quality initiatives, collaborate with GxP RDQA partners, and guide audits to resolve non-compliance while communicating clearly with stakeholders at all levels.

Qualifications

• This role requires a Bachelor's degree in science or equivalent experience.
• 7+ years in pharmaceutical industry in clinical development, regulatory affairs or quality assurance.
• Strong knowledge of quality systems, auditing standards, and global regulations (ICH, ISO).
• Excellent communication, negotiation and influencing skills; ability to manage complex issues.

Responsibilities

• Leads and develops a team of Clinical Auditors across the Americas.
• Contributes to global Clinical Audit strategy at Americas level.
• Provides leadership and insight to risk-based clinical audits and resolves non-compliance.
• Drives innovative quality strategies and collaborates with GDxP RDQA functions.
• Supports implementation of initiatives to ensure regulatory compliance and company policies.
• Analyzes processes to assure quality and compliance in clinical development.
• Communicates expectations clearly and maintains two-way dialogue with staff.
• Provides expert guidance on clinical regulations and inspection readiness.

Skills

Leadership

Quality systems

Auditing

Regulatory affairs

GCP/GLP

Cross-functional collaboration

Communication

Travel readiness

Education

Bachelor's degree in science

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.

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.

Job Description

• This role could be based in any of our hub locations (North Chicago, IL/Cambridge, MA/Worcester, MA/Florham, NJ/Irvine, CA/San Francisco, CA) in US
• Leads and develops a team of Clinical Auditors, based in the Americas, in the development and execution of all clinical audit types. Build a strategic, high-performing team that operates cross functionally to build-in quality to AbbVie processes from the outset.
• As part of the Clinical Audit Leadership Team, contributes to the development of the global Clinical Audit strategy while driving this at an Americas level.
• Provides leadership and strategic insight to the risk-based clinical audit program, execute more complex audits and work with auditees to resolve any non-compliance(s) identified.
• Leads and delivers innovative quality strategies and solutions through collaboration with business partners and other GxP RDQA functions to support effective and timely solutions to compliance issues and/or questions.
• Drives development/continuous improvement of necessary quality and clinical systems by leading and/or supporting implementation of initiatives to assure compliance to regulations and corporate policies.
• Analyses and evaluates processes that support clinical development in order to assure quality and compliance.
• Drives for results for self and staff by providing clear direction, establishing stretch goals/assignments and is able to communicate expectations and objectives in a clear and well-planned manner. Maintains two-way dialogue with others related to work assignments and results; brings out the best in people.
• Provides expert advice and support on clinical regulations, guidance and expectations to RDQA and business colleagues.
• Provide strategic input to the inspection support model and actively support GCP inspections onsite or remotely if needed
• Promotes continuous education on quality and clinical guidelines and regulations for self and other AbbVie staff.

Qualifications

• Bachelors degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
• 7+ years of experience in the pharmaceutical industry in the fields of clinical development, clinical trials regulatory affairs and/or quality assurance supporting those areas, or with a regulatory authority.
• Detailed knowledge of quality systems and auditing standards.
• Extensive knowledge of worldwide clinical regulatory requirements and industry best practices, quality management principles, including global and regional regulations and internationally recognized standards (e.g. ICH, ISO).
• 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 manage complex issues and distil information. Strong analytical skills and the ability to proactively identify, rapidly assess, and effectively manage business and compliance risks.
• Significant experience leading cross-functional and multi-location teams through complex projects with demonstrated flexibility to adapt to changing assignments and ability to effectively prioritize.
• Ability to think strategically and communicate effectively with colleagues at all levels, including senior management.
• Well-developed leadership competencies to deliver team objectives and projects.
• Willingness and ability to perform domestic and international travel

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 ingood faith it will pay for this role at the timeof thisposting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location,andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our long-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless anduntil paid andmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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