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 . on Twitter , Facebook , Instagram , YouTube and LinkedIn .
Job Description
This position sits onsite 3 days weekly at one of the following locations: North Chicago, IL; Irvine, CA; South San Francisco, or Ludwigshafen, LU.
Purpose:
Primarily responsible for carrying out tasks related to core job responsibilities by providing quality consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide
Responsibilities:
- Carryout job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies
- Independently plan and conduct internal system audits and external GxP supplier audits
- Maintain approved supplier list, global audit schedule and participate in supplier management processes
- Gathers internal and external audit metrics and presents to QA management for trend analysis
- Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
- Provide guidance and training on GxP regulations and guidelines to GxP auditors and functional areas personnel
- Assist GxP QA Management on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers
- Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities
- Expected to elevate any issues to management, as necessary, in meeting these responsibilities. Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight
- This is an experienced level compliance position that reports to the Associate Director GxP Compliance. This individual is expected to identify and resolve problems, through effective interpersonal skills. The incumbent will work effectively independently,
Qualifications
Qualifications:
- Bachelors degree preferably in life sciences or engineering
- Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilizing core & technical competencies
- 5+ years experience in function or related fields such as: thorough understanding of international GxP regulatory standards (e.g. GMP, GLP, GCP, GDP, GCLP, etc.), Quality Assurance / Regulatory Affairs,Pharmaceutical / Device / Healthcare Industry,Quality Assurance auditing experience (preferred),Laboratory experience (preferred)
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA)
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 believesingood faith it will pay for this role at the time of this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, and we mayultimatelypay 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/visioninsurance 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 payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensationand benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid andmay be modified at the Companys 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 AbbVies 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.