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.

Purpose

The Manager, CAPA & Post-Market Surveillance (“Manager”) is part of AbbVie’s Medical Device Center within the Shared Services function (“MDCSS”).  The Medical Device Center manages quality activities across a variety of medical devices and combination products, varying from U.S. Class I to Class III (and international equivalents); the Shared Services function serves in an above plant capacity with core emphasis on Product Life Cycle Management and related ancillary functions.  This position’s primary focus is on management of the supporting post-market processes, and reports to the Director, Medical Device & Combination Products Shared Services (or equivalent).

The Manager leads a team that processes, analyzes, and evaluates post-market data in accordance with EU MDR 2017/745, 21 CFR 820, SOR/98-282 and other relevant regulations. The Manager provides oversight and tactical assistance to their team to identify and escalate post-market trends, manages the actions to resolve manufacturing and supplier issues (e.g., CAPA), and serves as process owner for Post-Market Surveillance Reporting.  The Manager works cross-functionally to ensure robust integration of post-market quality activities with the quality risk management process.

The Manager serves as a key contact and advocate between various internal stakeholders (e.g., Regulatory Affairs, Medical Safety, Medical Writing, PMQA, etc.) and drives timely coordination and completion of activities.

Responsibilities

• CAPAs.  Manage CAPA Review Board (CRB) process for Devices & Combination Products, ensuring NCRs/CAPAs/SCARs are opened, as appropriate, to drive meaningful improvements. Oversee timely completion of NCRs/CAPAs/SCARs using a risk-based approach.
• Post-Market Trends.  Manage Potential Trend Evaluations (or similar) stemming from post-market data, ensuring the team completes investigations in a timely manner.  Use evidence-based information to escalate potential trends for further review.
• Post-Market Reporting.  Manage Post-Market Reporting process (e.g., PMCFP/PMCFR, PMSP/PMSR/PSURs, PRER, CER, etc.), providing tactical direction and assistance to internal and external stakeholders.  Maintain process in alignment with current MDCG, ISO standards, and regulations.
• Quality Audits.  Serve as SME during regulatory inspections in primary areas of responsibility.
• Quality Metrics.  Generate and maintain metrics, as requested, and use data to drive continuous improvement in assigned functional areas.  Escalate discrepancies and confirmed or potential Quality issues to management.
• Quality Projects.  Propose and lead projects intended to drive meaningful improvements in MDC.  Strive to ensure state-of-art processes and systems are developed.
• Team Leadership.  Develop a high performing team, ensuring direct reports are given opportunities to learn, grow, and utilize their strengths.  Ensure team maintains patient-centric focus.

Qualifications

• Bachelor’s Degree in a scientific/technical discipline with 8 years of experience in Medical Devices
• People leadership experience
• Working knowledge of EU MDR 2017/745, 21 CFR 820
• Direct experience managing CAPAs (≥ 3 years)
• Direct experience working in the Post-Market space.
• Ability to make sound judgements
• Ability to tailor mentorship and coaching based on staff’s individual needs
• Analytical, organized, with strong attention to detail
• Fluent in verbal and written English

Preferred Qualifications

• Experience with ComplianceWire, Global TrackWise, Polarion (Siemens) ALM, and OneVault
• Working knowledge of relevant MDCG and ISO standards
• Skilled in data analytics and CAPA tools
• ASQ Certification (e.g., CQA, CQE) or equivalent

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