Job Information
AbbVie Sr Program Manager, Quality GCP in Waltham, Massachusetts
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 Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose:
Cancer doesn’t care how it disrupts the course of lives. We do. Since our founding, we have pursued one goal: develop targeted cancer therapies to improve outcomes for cancer patients. This singular focus has positioned us as a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer. At AbbVie, each of us are driven by a shared conviction that by advancing precise, targeted cancer therapies, we have the power to offer more good days to patients and their families ― now. It is why we come to work each and every day, and it is what will continue to motivate and energize us in the years to come.
We are currently looking for an individual to join our Quality Team, willing to work in close collaboration with the Clinical, Regulatory, Translational Science, and Pharmacovigilance departments to ensure compliance with Good Clinical Practice(s), and other applicable regulations. This position is responsible for the assessing compliance of the company as well as that of company vendors/CROs/clinical sites.
Responsibilities:
Conduct or facilitate internal and external audits, including clinical site, vendor/CRO, Trial Master File, and internal process audits, as needed.
Oversee vendor performance and deliverables
Perform a quality assurance review of documents and data intended for regulatory submission.
Ensure internal and external (clinical sites/vendors/CROs) adherence to GCP, GLP, and applicable regulations.
Assist in the writing and/or reviewing of SOPs for the GCP compliance program, quality documentation such as quality agreements
Perform quality assurance and GCP compliance review of various clinical study documentation such as study protocols, ICFs, monitoring plans, clinical study reports, etc.
Manage deviations and CAPAs through completion.
Assist in the development, tracking, and reporting of quality metrics.
Assist in evaluating and investigating clinical study non-compliance, quality events, quality queries, and complaints.
Communicate any critical compliance risks noted from these activities to QA management.
Perform related duties as assigned by supervisor.
Maintain compliance with all company policies and procedures.
Qualifications
Qualifications:
BS/BA in the field of science such as chemistry, microbiology, biology and biochemistry or BS in a related science field such as Regulatory Science.
Three - five years in a GCP environment with at least three years working in a role supporting GCP compliance.
Experience in site monitoring, inspection readiness or leading and conducting clinical site, vendor/CRO, and internal process audits.
Practical knowledge of GCP guidance and regulations and FDA inspection process.
Proficient in Microsoft Office suite (Word, Excel, Powerpoint).
Proven ability to identify and effectively resolve quality issues and gaps; a practical approach to problem solving.
Experience with CRO management oversight or experience at a clinical trial site preferred.
Ability to work independently and within a group setting and to interact effectively with internal customers, including Clinical, Medical and Pharmacovigilance functions.
Strong communication skills (oral, written, and interpersonal) including the ability to give training in aspects of GCP compliance.
Excellent attention to detail, time management, and investigative skills as well as the ability to manage multiple priorities.
Demonstrates good judgment and decision-making experience.
Demonstrates flexibility in dealing with change and diversity.
Relationship-building skills.
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.
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.