Job DescriptionThe Manager, Quality Assurance & Continuance Improvement holds the responsibility of managing the
Quality Assurance team across the function. The role is responsible for the direct oversight of the Quality
System, including owning and operating the Monthly Review Board (MRB), CAPA program, and managing
all aspects of the Quality Monitoring program. The role is also responsible for maintaining the documentation
control system to ensure proper controls and accountability and support internal and external audits. The
positions manages the quality and continuous improvement strategy, while managing an organization of
quality assurance and data-driven insights personnel.
Responsibilities
- Manages the Quality Assurance team, responsible for selection and hiring, setting performance expectations, and development of staff.
- Assists with the overall development and implementation of organizational Performance Improvement (PI) plan, including identification of PI goals, coordinating and participating in PI projects, and reporting activities and outcomes.
- Manages investigations (ERs), including oversight of complaints, non-conformances, CAPA and deviations, identifying improvements and responding to trends.
- Manages quality and performance metrics and Key Performance Indicators (KPIs) for the larger function, utilizing trend and data analytics to prioritize areas of opportunity, and leading projects and efforts to drive improvements.
- Reviews, and approves, Quality System documents and records.
- Manages organizational Risk Management process, partnering with OEC and BTS in driving improvement in privacy and security efforts.
- Supports internal and external audits, provides audit responses, and develops improvement plans based on audit feedback.
- Responsible for monthly Management Review Board (MRB) meeting, collaborating with quality team and larger organization in presenting quality trends, remediation efforts, and impact metrics.
- Oversees monitoring tools and supports expansion of automated quality monitoring and analytics where appropriate. Support other functional quality initiatives, programs and systems as required.
Qualifications- Bachelor's degree in business, physical or life science, pharmacy, nursing, engineering or related field if combined with relevant work experience
- 5+ years experience in quality assurance, service center or technical field in a regulated industry or relevant experience
- 3+ years of managerial and/or project management experience in a quality assurance, or similar organization highly desired
- Knowledge of AbbVie Quality System, or similar, specifically governing policies and procedures related to Quality Assurance best practices
- Experience driving key process improvement initiatives based on data-driven insights and key performance indicators (KPIs)
- Ability to represent the Quality function effectively with senior managers, other AbbVie and external professionals
- Strong communication skills and ability to effectively collaborate with stakeholders across the organization
- Six Sigma / continuous improvement methodology, certification, or experience is preferred
- Regulatory, compliance, and/or information security experience is desired
Additional InformationApplicable 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 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.
