Senior Manager Medical Device Quality Systems
Senior Manager Medical Device Quality Systems
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Salary Not Disclosed
1 Vacancy
Job Description
Purpose
The Sr. Manager Medical Device Quality Systems is responsible for supporting the sustainment improvement and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. The role serves as Deputy Person Responsible for Regulatory Compliance under EU MDR 2017/745 providing compliance subject matter expertise to internal business partners demonstrating AbbVie quality management system compliance to external regulators and leading continuous process improvement & globalization initiatives with other crossfunctional AbbVie team members.
Responsibilities:
- Serves as the Deputy Person Responsible for Regulatory Compliance under EU MDR 2017/745 supporting quality management supervision under the direction of the Management Representative.
- Hosts External Audits demonstrating AbbVie quality management system compliance to external regulators for ISO 13485 and other countryspecific device audits under MDSAP.
- Conducts Internal Audits to assess the compliance of AbbVie quality management system in accordance with ISO 13485 and other countryspecific device regulations under MDSAP.
- Leads root cause investigation and corrective action planning in response to external and internal audit observations in collaboration with departmental process owners and subject matter experts.
- Maintains expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
- Performs regulatory compliance assessments to support the decisionmaking in critical business decisions including Market Actions.
- Analyzes & interprets quality system performance metrics presenting to Top Management as part of Management Reviews.
- Program manages initiatives intended to improve and globalize the AbbVie quality management system.
Qualifications :
- Bachelors degree preferably in engineering physical science (e.g. Chemistry) life science (e.g. Microbiology or Biology) or pharmacy and a minimum of 8 years of industry experience in a GXP regulated environment with a minimum 3 years in Quality Assurance Operations Management. A strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate understand and direct individuals in highly specialized technical fields.
- ISO 13485 Lead Auditor certification by a professional body is required. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQOE) Six Sigma Black Belt Certification or Project Management Professional (PMP) Certification.
- Quality Assurance Quality Control Regulatory Manufacturing Laboratory or Validation background in a GXP regulated environment is required.
- Thorough documented understanding/knowledge of GXP regulations.
- Regulatory inspection experience preferably with direct agency inspector interaction.
- Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
- Strong project management skills are essential.
- Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
- Key leadership competencies include cultural awareness relationship building ability to influence at all levels of the organization teamwork building sound judgement and the ability to make difficult decisions often at short notice.
Key Stakeholders
External Manufacturing Business Relationships Operations Third Party
Manufacturers Business Alliance Commercial Global Supply Chain Domestic and International AbbVie Plants and Affiliates Regulatory Affairs Research and Development.
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 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.
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Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
