QA Compliance Manager

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. 

The QA Compliance Manager will provide leadership and direction for the site compliance programs to ensure that our products meet established quality requirements and that the site is in compliance with regulatory requirement including: 

1. Deploys Quality Compliance programs to support quality objectives.
2. Manages Inspection Administration programs.
3. Manages key compliance programs, such as the CAPA, internal audit, policy deployment, management review and supplier monitoring. Assures the site is prepared for inspections.
4. Manages site Internal and Supplier audit programs. Assure audit schedules are created and approved. Identifies and reports critical compliance-related issues to senior management. Provides recommendations for action plans as appropriate.
5. Serves as a knowledgeable site resource about quality systems and compliance.
6. Acts as Inspection Administrator, effectively managing all inspections of the site by external regulatory agencies, Corporate Auditing, and Customer audits.

Responsibilities

• Provides direction to staff of professionals to include hiring, setting performance expectations, performance feedback and development of staff.
• Directs the development of Quality policies that meet both regulatory and company requirements.
• Maintains expertise on various regulations (FDA, EMA, ICH, etc.)
• Reviews and approves key quality documents.
• Provides compliance leadership to the manufacturing site.
• Provides direct interface with FDA and other regulatory agencies. Develops and communicates
  tone for successful, cooperative inspection. Directs any and all resources necessary to participate in audit.
• Compiles, analyzes and communicates significant quality or compliance metrics to senior management.
• Interacts directly with regulatory agencies and clients during inspections.
• Establish programs to promote quality awareness and compliance.

Qualifications

• Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• PharmD is strongly preferable
• 8+ years of Biopharmaceutical quality and compliance experience
• Demonstrated ability to effectively interface with regulatory agencies
• Quality Assurance/Regulatory Affairs/Compliance experience required
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• Able to demonstrate extensive knowledge of plant and company-level procedures.
• Ability to evaluate quality, production, and support areas for compliance with GMPs. BOPs, etc.
• Strong decision making skills
• Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve

Applicable 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. ​

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AbbVie 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.