GMP Operational 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.

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* Key Responsibilities:

** The responsibilities of this position may include, but are not limited to, the following:
Assists Change Control owners with ensuring compliance to change procedure requirements, assesses and approves change controls.
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* 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.  leadership skills with the ability to work in a fast-paced environment and meet quality, 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.

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  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.
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