Senior Manager, GMP Operational Quality (Hybrid)

Boston, MA, United States

Senior Manager, GMP Operational Quality (Hybrid) page is loaded Senior Manager, GMP Operational Quality (Hybrid) Apply locations Boston, MA time type Full time posted on Posted 2 Days Ago job requisition id REQ-21769 Job Description

General Summary:

The Sr. Quality Manager is an advanced technical resource in the principles and application of quality assurance and compliance. The Sr. Quality Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects , effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

Key Duties and Responsibilities:

Provides Quality support for external manufacturing of drug product and performs batch disposition activities

Collaborate with internally 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

Assesses and approves 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.

Identify, facilitate, and/or lead continuous improvement efforts

Maintains Quality Metrics to support process improvement activities

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

Assists in preparation of audit responses

Manages audit CAPAs & metrics

Provides technical advice for partner and regulatory agency audits

Provides information to assist in budgeting and scheduling

Knowledge and Skills:

In- depth knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing

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

In-depth experience leading complex projects and continuous improvement initiatives within stated objectives and timelines; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks

Ability to independently lead cross-functional teams and represent the Quality unit

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., QDoccs, Veeva)

Education and Experience:

Bachelor's degree in a scientific or allied health field (or equivalent degree)

Requires 6 years of experience, or the equivalent combination of education and experience

Experience providing Quality support and oversight of GMP manufacturing operation including batch disposition

Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting

Knowledge of cGMP requirements governing oral drug products manufacturing practices

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as:

Hybrid: work remotely up to two days per week; or select On-Site : work five days per week on-site with ad hoc flexibility.

#LI-Hybrid #LI-ND2

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 at [email protected].

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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry's top places to work, including 14 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com  or follow us on Facebook , Twitter/X ,  LinkedIn ,  YouTube  and  Instagram .

The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people’s lives.

Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.

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