Director, Site Quality

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at ***. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok (***/@abbvie) .

This role is responsible for the implementation of a strong quality culture across all of AbbVie Operations by providing support, oversight and ensuring that all areas are operating in a compliant manner with applicable external regulatory requirements for pharmaceuticals, devices, biologics, combination products and OTCs. Serves as a leading subject matter expert for GXP and the AbbVie Quality System.

Responsibilities:

• Ensure quality activities are defined and can be executed consistently to the most stringent international quality and compliance standards.

• Drive and foster a strong quality culture with openness, honesty and innovation.

• Support sites in audit preparation/readiness

• Perform on-site simulated audits at our sites. Perform affiliate and site functional audits. Perform audits of key suppliers.

• Provide mentoring and training to support development and succession planning.

• Provide technical and regulatory guidance to the AbbVie Network. Provide direction for continuous improvement programs for key operational activities.

• Lead a QS Center of Excellence (CoE) and support the CoE team.

• Support sites in representations to government bodies and in regulatory investigations. Support sites and the global network with complex investigations.

• Represent the AbbVie at regulatory meetings by providing presentations or participating on panels.

• Recruit and develop key talent to ensure effective succession planning.

Qualifications

• Bachelor's degree required, preferably in Physical or Life Sciences, Pharmacy, or Engineering

• 12+ years of combined experience in manufacturing, QA, R&D in pharmaceutical industry OR 10 years of Quality Management experience OR 5 years of experience as a Regulator Command of domestic and international GMP and quality regulations (e.g. USFDA, CFRs, EU et

• Advanced knowledge of pharmaceuticals, devices, biologics, combination products and OTCs.

• Superior verbal and written communication skills to executive management and other stakeholders

• Excellent indirect influencing skills and experience in dealing with international locations and diverse global cultures.

• Must be able to establish and maintain effective working relationships stakeholders in manufacturing, product development, Quality and Regulatory Affairs.

• Ability to work in a fast-paced, high pressure and changing environment in an autonomous manner. Flexibility to adapt to changing conditions and ability to effectively prioritize.

• Ability to travel globally up to 40% as required, and to utilize technology to stay connected across all major time zones.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

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• 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​

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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.

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

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Salary: $151,500 - $288,000