Operational Area Quality Senior Manager

Job Description

General Summary :

The Senior Manager Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. The Senior Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. This role is responsible for primary QA oversight of commercial drug product manufacturing performed at Vertexs external vendors. The role also provides supporting oversight for commercial drug substance operations. This position ensures robust sterile manufacturing controls commercial supply continuity support for global jurisdictional expansion and highlevel combination product quality alignment.

Key Duties and Responsibilities :

Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions

Participates in cross-functional teams as an experienced Quality technical resource

Drafts and enforces Quality Agreements between CMOs / Suppliers and Vertex as needed

Assists Change Control owners with ensuring compliance to change procedure requirements

Initiates and assesses change controls

Conducts quality investigations / deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.

Ensures appropriate CAPA actions are identified and addressed.

Approves investigations / CAPAs.

Performs review and approval of master and executed batch records to support drug substance (DS) drug product (DP) device (Autoinjector) and finished goods (FG) disposition activities

Lead DP governance supplier performance monitoring and improvement quality risk reviews and partnering with external manufacturers.

Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems

Conducts GMP document review including procedures work instructions specifications methods protocols and method reports

Responsible for coordinating facilitating and follow up on any QLT action items assigned.

Identify and communicate risks and assist with risk mitigation plans as necessary

Supports internal audit or external audit programs

Provide QA support for regional / global submissions supporting new market entry or postapproval changes.

Provides technical advice for partner and regulatory agency audits

Knowledge and Skills :

In- depth knowledge of both the conceptual and practical application of cGMPs in a biologics and devices pharmaceutical setting; in-depth knowledge of global GMP requirements in support of GMP manufacturing and / or device assembly

Strong team leadership skills with the ability to work in a fast-paced environment and meet quality accuracy and timeliness objectives

In-depth experience managing complex projects with contract manufacturing organizations and continuous improvement within stated objectives and timelines; effectively applies project management processes / tools to address quality initiatives in meetings assist with planning and facilitate completion of tasks

Strong experience in identifying assessing and mitigating potential risks utilizing quality risk management best practices

Ability to mentor and guide less experienced colleagues skilled at transferring technical knowledge and teaching quality management skills

Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex and sensitive information and is able to influence others to understand a point of view and gain alignment around a proposed action

Demonstrated ability to work independently to provide QA advice for large multifaceted projects

Demonstrated ability to evaluate quality matters and make complex decisions leveraging technical experience and advanced judgement and the analysis / synthesis of a variety of information; able to work outside of precedent and takes a new perspective on existing solutions

Strong experience successfully leading event investigations Root Cause Analysis (RCA) and CAPA

Strong experience with electronic document management systems (e.g. Veeva)

Education and Experience :

Bachelors degree in a scientific or allied health field (or equivalent degree)

Typically requires 6 years of experience or the equivalent combination of education and experience

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Pay Range : $132900 - $199400

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 :

Hybrid-Eligible Or On-Site Eligible

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 Vertexs 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 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 :

Senior Manager

Key Skills

Direct Sales,Food Safety Experience,Management Experience,Process Improvement,Produce Experience,Rigging,Retail Sales,Operations Management,Quality Control,Enterprise Sales,negotiation,Sales Support

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 132900 - 199400