Operational Area Quality Manager

Job Description

Employer: Vertex Pharmaceuticals Incorporated 

JOB TITLE: Operational Area Quality Manager

LOCATION: Northern Ave., Boston, Massachusetts, 02210

OPENINGS:

DUTIES:

• Responsible for generating performance metrics and identifying trends.
• Provide QA support of change controls, investigations, CAPA's 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 CAPA's.
• 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 Bachelor's 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: $113, $169,800.00

CONTACT: Send Resume to Reference EOE.

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Pay Range:

Disclosure 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:

Flex 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 Vertex's Policy on Flex @ Vertex Program and may be changed at any time. 

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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 person's 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