Operational Area Quality Manager (HybridOnsite)
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Job Location:
Boston, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
02-11-2025
Vacancies:
1 Vacancy
Job Summary
Job Description
Employer: Vertex Pharmaceuticals Incorporated
JOB TITLE: Operational Area Quality Manager
LOCATION: 50 Northern Ave. Boston Massachusetts 02210
OPENINGS: 1
DUTIES:
- Responsible for generating performance metrics and identifying trends.
- Provide QA support of change controls investigations CAPAs and effectiveness checks.
- Lead meetings as necessary and collaborate with customer groups to ensure quality systems are monitored and established metrics are met.
- Participates in compliance walkthroughs of the site and help to drive the closure of any observations.
- Responsible for identifying risks and communicating gaps for process/systems.
- Participate in continuous improvement of department processes and ensure the team continues to meet expanding business needs.
- Participate in inspection readiness activities and provide support during regulatory site inspections.
- Support the vendor management process including the creation and review of Quality Agreements with suppliers.
- Draft review and manage approval of quality system documentation including but not limited to deviations change controls and CAPAs.
- Support internal audits as applicable.
- Assist with addressing product complaints.
- May manage the day to day activities for a Quality Assurance.
Telecommuting up to 40% permitted.
REQUIREMENTS: Employer will accept a Bachelors degree or foreign equivalent in Drug Regulatory Affairs Scientific or Allied Health Field or a related field and 4 years of experience in the job offered or in Operational Area Quality Manager-related occupation.
Position requires demonstrable experience in the following:
Experience with both the conceptual and practical application of Current Good Manufacturing Practices (cGMPs) in a pharmaceutical setting. Experience with leading a variety of projects and teams within stated objectives and timelines. Experience in leading quality projects including continuous improvement gap assessment gap remediation quality system and process launch. Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions. Highly proficient in leading event investigations Root Cause Analysis (RCA) and Corrective Action Preventative Action (CAPA). Experience with electronic document management systems including QDoccs Trackwise or Veeva or other Quality Management System.
Rate of Pay: $113200.00- $169800.00
CONTACT: Send Resume to . Reference 12140.439. EOE.
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Pay Range:
$0 - $0Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors including skills competencies experience and other job-related factors permitted by law.
At Vertex our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career financial family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter) educational assistance programs including student loan repayment a generous commuting subsidy matching charitable donations 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:
In this Hybrid-Eligible role you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertexs Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
Company Information
Vertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry ethnicity disability veteran status genetic information sexual orientation marital status or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager or contact Talent Acquisition at
Required Experience:
Manager
Key Skills
- Computer Science
- Operational Risk Management
- Risk Management
- Six Sigma
- Continuous Improvement
- Lean
- Process Improvement
- Pricing
- Customer Support
- Alteryx
- Kaizen
- Project Management Lifecycle
About Company
Vertex Pharmaceuticals invests in scientific innovation to create transformative medicines for people with serious diseases.
