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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

This position is reporting to the Site Quality Lead directly. This position interacts with all plant departments and AbbVie Corporate groups as the quality technical specialist for implementation, qualification, documentation, and compliance of operations equipment, utilities, computer systems, and software at the BLI manufacturing site. The role will specialize in administering the Data Governance quality system with focus on electronic record data integrity, data life-cycle management, data risk assessments and controls as well as quality review and approval of computer system qualifications.

Representing Quality for site implementations and changes of utilities, equipment, and computer systems including the following:

• Provide quality system guidance, review, and approval of in scope change controls.
• Provide Data Governance quality system guidance and oversight for operations and laboratory electronic records and data systems.
• Review and approve utilities/equipment/systems procedures and drawings.
• Review and release utilities, equipment, and computer systems for GMP use.
• Review/approve various qualification/validation plan and lifecycle documents, risk lifecycle documents, test strategies, test documents, summaries, and certification packages and associated deliverables as appropriate.
• Provide guidance, quality reviews and approvals for calibration and metrology documentation of operations and laboratory systems.
• Participate and take quality lead on process improvement projects. Approve key project deliverables.
• Providing subject matter expert support and reviews of applicable quality systems including Data Governance, CAPA, change control, OOT/OOS, complaints, audits, risk management, and Facility work order systems. Supporting any plant or corporate driven initiatives to enhance these systems.
• This position is responsible for assessing and approving quality system documentation. This includes implementing and coordinating all activities relating to the control, maintenance, and closure of GMP Quality documentation. Creation and revision of appropriate procedures to assist in the management of the Quality System.
• This individual must be able to present and defend Quality records and data package during External Ministry of Health inspections. Responsible for review and approval of audit observation responses.
• Utilize quality risk management principles in decision making.
• Provide training for applicable quality systems. Provide guidance and supervision to AbbVie and contracting staff.

Regulated Responsibilities (including cGMP and EHS):

AbbVie is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to: the FDA, CDC, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, all other applicable MOH regulations and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.

Qualifications

Education and Experience:

• Education is equivalent to a 4-year college degree, with and emphasis in a technical discipline such as Engineering, Biochemistry, Chemistry, Chemical Engineering, or Microbiology. Additional scientific training M.S., PhD, and/or MBA, preferable.
• 10 years of experience in a commercial/clinical biologics manufacturing environment with a minimum of 3 year’s experience as a Quality Engineer or Quality Assurance. Sound technical skills including working knowledge of biologics and bio­pharmaceutical production, quality assurance, analytical testing technologies and computerized systems.
• An understanding of US/OUS cGMP regulations, and experiences in regulatory inspection is required.
• Experience with qualification of laboratory, manufacturing, utilities equipment and associated computer system is required.

Essential Knowledge, Skills, and Abilities:

• Excellent judgment and decision-making capability in the technical and compliance arenas.
• In depth knowledge of Data Governance and Data Integrity requirements in a regulated environment is required.
• Must have excellent Organizational Skills. Must be detail and quality oriented.
• Ability to handle a wide variety of tasks under time constraints.
• Ability to interpret multiple standards and apply to department activities.
• Ability to interpret and evaluate data and summarize results.
• Be open to take on novel approaches to establish and maintain effective relationships with co-workers and subordinates.
• Excellent oral, presentation, and written skills
• Able to work with Chemicals and solvents, Biological product including controlled substances and toxins. The handling of drug compounds and excipients. An environment where gowning and respirators is required.
• Ability to establish and/or maintain electronic databases (i.e., Non-Conformance, change control, training documents, etc.).

Additional Information

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​

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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

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

https://www.abbvie.com/join-us/reasonable-accommodations.html

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

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

https://www.abbvie.com/join-us/reasonable-accommodations.html