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 www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

• Creates and implements short and mid-term GMP compliance strategies for the Analytical R&D (ARD) functions guided by global regulatory requirements, while effectively managing local and global interfaces across Small Molecule and Biologics Analytical R&D functions (SMARD/BARD), CMC Regulatory Affairs (RA), Quality Assurance (QA), CMC Coordination, Product Development Science and Technology (PDS&T), among others.
• Develops and aligns in close cooperation with stakeholders globally, phase-appropriate lean development processes, workflows, and GMP approaches for ARD cross-functionally.
• Authors, reviews, and approves Standard Operating Procedures (SOPs) specific to ARD while advising on other compliance harmonization activities including GMP documentation practices, laboratory investigations, corrective/preventative actions (CAPA), and local area audit activities.
• Influences mid- and long-term strategic focus areas of the Global Analytical Strategy and Operations (GASOps) team and articulates / negotiates new development approaches across organizations.
• Utilizes leadership and functional expertise to provide input to department strategies, champion decisions, and influences without authority.
• Initiates and leads global cross-functional initiatives to improve processes and workflows.
• Leads, develops, and coaches leaders and scientists across multiple organizations through matrixed teams.
• May be responsible for a multilevel group of up to 5 people.
• Translates functional vision into actionable strategies.
• Stays current on global regulatory expectations and trends (via guidelines, GMPs, trade organizations, and other GxPs as appropriate) while translating these into executable and lean approaches aligned with partner functions.
• Drives/coordinates operational decision making on a global basis.
• Adapts to changing environments and balances priorities.
• Ensures utilization of appropriately risk-based approaches to ensure project and internal/external budget success and increase efficiency.
• Supports project development of technological innovations by providing guidance on regulatory / GMP expectations.

Qualifications

• Bachelor’s + 14 years, Master’s + 12, PhD + 6 years in pharmaceutical sciences, chemistry, food sciences or related field is required. Advanced degree is preferred.
• Must have demonstrated extensive knowledge and experience in analytical and/or formulation development with solid cross-discipline exposure and knowledge including international pharmaceutical regulations and cGMPs.
• Thorough understanding of how to interpret and translate global regulatory requirements into appropriate and efficient processes and workflows.

Prior experience in managing matrix teams is expected.

• Builds strong relationships with peers to create and implement cross-departmental (Regulatory, QA, PDS&T) compliance strategies.
• Motivates and influences others to manage global business partners.
• Knows the business to influence long-range strategies.
• Creates a learning environment, open to suggestions and experimentation for improvement while recruiting, developing and retaining top talents.
• Deals comfortably with uncertainty, ambiguity, and risk to make decisions having mid-term impact. Ensures alignment with corporate/regulatory policies/standards.
• Steps up and takes leadership to implement changes in the face of organizational or personal challenges.
• Raises the bar and drives the function to efficient/reliable execution.
• Learns fast, grasps the essence and can change course quickly where indicated to manage and prioritize resources & timelines across a wide range of development programs/scientific initiatives within area of responsibility.

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. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html