GMP Operational Quality Manager

Quality Manager

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

Key Responsibilities:

• Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to analytical testing at contracted suppliers.
• 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.
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports.
• Performs disposition activities in support of Commercial products.
• 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.

Minimum Qualifications:

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 and analytical lab testing.
• Strong team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives.
• Experience leading complex projects/teams 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 staff, 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, 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:

• Bachelor's degree in a scientific or allied health field with 5+ years of relevant work 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 substance, spray dried dispersion (SDD) and 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.

Pay Range: $118,400 - $177,600

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

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 View email address on click.appcast.io