Vertex Pharmaceuticals
Operational Area Quality Associate Director
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Operational Area Quality Associate Director
General Summary
The Associate Director, GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertex’s external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high‑level combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams.
Key Duties And Responsibilities
Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms
Enable team to achieve team goals/objectives and enable their individual career development
Develop and maintain compliant quality processes to support GMP activities
Oversee the QA support of Change Controls, GMP investigations and associated 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
Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes
Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.
Support review of regulatory submissions, as applicable
Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
Lead 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
Provide comprehensive knowledge support for partner and regulatory agency audits
Assist management team in budgeting and scheduling
Responsible for the following activities related to people management responsibilities:
Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding
Accountable to provide oversight of day to day team operations
Knowledge And Skills
In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing
Demonstrated success in building high‑performing teams and skilled at managing team and individual development
Strong management skills with the ability to lead and motivate a team in a fast‑paced environment while maintaining a high degree of quality, accuracy and timeliness
Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
Ability to independently lead cross‑functional teams and represent the interests, strategies and objectives of Quality unit
Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development
Ability to communicate cross‑functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action
Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk‑based approach; identifies and leverages the appropriate expertise to implement solutions
Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
Supstantial experience with electronic document management systems (e.g., Veeva)
Education And Experience
Bachelor's degree in a scientific or allied health field (or equivalent degree)
Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experience
Pay Range $154,100 - $231,200
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
Hybrid: work remotely up to two days per week; or select
On‑Site: work five days per week on‑site with ad hoc flexibility.
Company Information Vertex is a global biotechnology company that invests in scientific innovation.
Equal Employment Opportunity Statement 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 ApplicationAssistance@vrtx.com
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Key Duties And Responsibilities
Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
Oversee CMO/Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms
Enable team to achieve team goals/objectives and enable their individual career development
Develop and maintain compliant quality processes to support GMP activities
Oversee the QA support of Change Controls, GMP investigations and associated 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
Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes
Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.
Support review of regulatory submissions, as applicable
Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
Lead 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
Provide comprehensive knowledge support for partner and regulatory agency audits
Assist management team in budgeting and scheduling
Responsible for the following activities related to people management responsibilities:
Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding
Accountable to provide oversight of day to day team operations
Knowledge And Skills
In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing
Demonstrated success in building high‑performing teams and skilled at managing team and individual development
Strong management skills with the ability to lead and motivate a team in a fast‑paced environment while maintaining a high degree of quality, accuracy and timeliness
Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
Ability to independently lead cross‑functional teams and represent the interests, strategies and objectives of Quality unit
Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development
Ability to communicate cross‑functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action
Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk‑based approach; identifies and leverages the appropriate expertise to implement solutions
Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
Supstantial experience with electronic document management systems (e.g., Veeva)
Education And Experience
Bachelor's degree in a scientific or allied health field (or equivalent degree)
Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experience
Pay Range $154,100 - $231,200
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
Hybrid: work remotely up to two days per week; or select
On‑Site: work five days per week on‑site with ad hoc flexibility.
Company Information Vertex is a global biotechnology company that invests in scientific innovation.
Equal Employment Opportunity Statement 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 ApplicationAssistance@vrtx.com
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