QA Superintendent

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 Superintendent will provide direct guidance and lead the team on decisions required to ensure the Quality, Safety, and Efficacy of the manufactured product. Responsible for implementing and maintaining the effectiveness of the Quality Systems. Collaborate with cross-functional teams in troubleshooting activities directed to improve the process and avoid reoccurrence of events. Provides direct guidance on the resolution of events. Lead continuous project improvement to avoid compliance issues. Ensure batch records review, audit and product disposition activities are performed according to AbbVie policies and procedures.

Responsibilities

• Oversee the auditing of production batch records of Active Pharmaceutical Ingredients (API)/Drug Substance (DS) and Drug Products (DP) for full compliance to written procedures prior to approval and release.
• Supervise Quality Assurance personnel responsible to perform auditing of production batch records of Active Pharmaceutical Ingredients (API)/Drug Substance (DS) and Drug Products.
• Ensure timely disposition of the products in SAP system. Ensure material control and product disposition is performed according to applicable restrictions management system. Issue batch documentation packages related to product release and act as the main liaison with other Abbvie sites to which the product will be transferred/shipped.
• Manage/Approve CAPA investigations and manufacturing events including approval of batch
  record discrepancies and electronic records exceptions. Approve and/or develop product impact analysis and corrective and preventive action for events.
• Responsible for leadership and completion of departmental projects and improvement of the Quality
  systems.
• Participates from local and global forums such as Shop Floor Control meeting, Change Review Board, Material Review Board, Investigation Review Board, as applicable.
• Responsible to hire, lead and develop team members to ensure that the department has the appropriate talent and level of performance to meet business objectives. Assure training and development of subordinates. Assist subordinates in problem solving. Identify and resolve personnel issues.
• Maintain an effective liaison and cooperative relationship with other Quality areas in the site and global functions (PQA, TPM QA, etc.) departments.
• Assure fulfillment of environmental, health, and safety EHS requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process.

Qualifications

• Bachelor Degree in Natural Sciences with eight (8) years of relevant experience in a Quality Assurance Operations role in the biologics or pharmaceutical industry. Masters Degree with six (6) years of relevant experience in a Quality Assurance Operations role role in the biologics or pharmaceutical industry.
• Three (3) years of experience as a People Leader preferred.
• Knowledge and comprehensive understanding of biological and/or pharmaceutical technologies.
• Capable of operating within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously.
• Excellent verbal and written communication in both English and Spanish.
• Knowledge of GMP, safety regulations.
• Computer literate including but not limited to Microsoft Office (Excel, PowerPoint, Word).
• Capable of handling multiple priorities.
• Strong problem solving, strategic and negotiation skills. Strong Interpersonal and leadership skills.

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. ​

​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 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.