Clinical Quality Management, Associate Director - Boston, United States - Vertex Pharmaceuticals

Vertex Pharmaceuticals

Verified Company

Boston, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

Description

Job Description

General Summary:

Reporting to the Director of Inspection Excellence within Clinical Quality Management, the Clinical Quality Management Associate Director will support the management and operational oversight of Quality Events and is responsible for leading Quality Event Management activities for Global Clinical Operations (GCO) assigned unplanned deviations, corrective/ preventive actions, and effectiveness checks.

Key Duties and Responsibilities:

Lead Quality Event Management activities related to the investigation, root cause analysis and development of corrective action/ preventive action plans for GCO assigned events, including unplanned deviations, corrective/ preventive actions and effectiveness checks ensuring timelines for closure are met.
Ensure visibility to and manage awareness of any noted deviations, issues or deficiencies by escalating to management.
Identifies and solves complex technical and operational problems, leveraging the appropriate resources.
Generate and analyze weekly, monthly and quarterly metrics.
Provides strategic input to solve complex problems while exercising judgment using multiple sources of information.
Develop solutions that fully address business needs and align standards (Proficient)
Communicate clear and convincing opinions, ideas, and positions, tailored to the audience, in a poised, confident, and convincing manner (Proficient)
Ensure all activities align with corporate requirements for training
Serve as technical resource for audits/inspections as needed
Ensure consistency in processes throughout all functions in Global Clinical Operations

Knowledge and Skills:

Advanced understanding of GCP, CFR and ICH guidelines
Significant experience participating in clinical quality activities and indepth knowledge of clinical operations
Possess strong critical thinking skills with a focus on inspection readiness.
Significant experience with investigations, root cause analysis and corrective action and preventive action plan development.
Leverage knowledge of organizational goals and interdependencies with other functional areas to drive success.
Demonstrated attention to detail, accuracy, excellent review and analytical skills in a fastpaced environment.
Results oriented
Significant experience with guiding and coaching employees
Excellent interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
Excellent verbal and written communication and presentation skills
May lead a department or subdepartment initiative.

Education and Experience:

Bachelor degree in a life sciences discipline
Typically requires 8 years of experience, or the equivalent combination of education and experience, in the biopharmaceutical industry

Pay Range:
$157,760 - $236,640

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 jobrelated factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive marketleading 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 weeklong 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.

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.