Operational Quality Manager

Title: GMP Operational Quality Manager

Location: 5000 - Vertex US - Fan Pier

time type

Full time

job requisition id

REQ-28043

Job Description

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 Manageradapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

Key Responsibilities: 

The responsibilities of this position may include, but are not limited to, the following:

• 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.

• Ensuresappropriate CAPAactions areidentifiedand addressed.

• Approves investigations/CAPAs.

• Identify,facilitate, and/orleadcontinuous 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,facilitatingandfollowup on any QLT action items assigned.

• Identifyand communicate risks andassistwith risk mitigationplansas necessary.

• Supports internal audit or external audit programs.

• Assistsinpreparationof audit responses.

• Manages audit CAPAs & metrics.

• Providestechnical advice forpartnerand regulatory agency audits.

Minimum qualifications:

Knowledge and Skills:

• In-depth knowledge of both the conceptual and practical application ofcGMPsin a pharmaceutical setting; in-depth knowledge of global GMP requirements and support of GMP manufacturing and analytical lab testing.

• Strong teamleadership skills with the ability to work in a fast-paced environment and meet quality,accuracyand timelinessobjectives.

• Experience leading complex projects/teams and continuous improvement initiatives within statedobjectivesand timelines; effectively applies project management processes / tools to lead meetings,assistwith project planning, andfacilitatecompletion 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-functionallytoa wide variety of audiences;exchangescomplex and sensitive information andis able toinfluence others to understand a point of view and gain alignment around a proposed action.

• Demonstrated ability to work independently toprovideQA advice for large, multifaceted projects.

• Demonstrated ability to evaluate quality matters and make complex decisionsleveragingtechnical experience, advancedjudgementand the analysis/synthesis of a variety of information; able to work outside of precedent andtakesa new perspective on existing solutions.

• Strongexperience successfullyleading event investigations, Root Cause Analysis (RCA), and CAPA<span>.

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

Education and Experience:

• Bachelor’s degree in a scientific or allied health field with5+ years of relevant work experience, or the equivalent combination of education and experience.

• Experience providing Quality support and oversight of GMP manufacturing operation including batchdisposition.

• 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 cGMPrequirementsgoverning 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. 

#LI-Hybrid
 

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.