Description

Job Description

The Senior Director, Project Management and Strategic Operations, is a key leadership role that will provide strategic leadership and direction to the advancement of the framework, capabilities, and sustainability of the compliance function in driving leading practices and keeping pace with the evolving organization and industry. This role will provide strategic direction and oversee the vendor qualification and compliance oversight program across areas ensuring effectiveness of risk management strategies across third parties and internal vendor management. This role will also provide strategic direction and oversee advancement of the inspection readiness framework with responsibility for strategic management and hosting of regulatory inspections, as well as, oversight of effective and sustained quality risk mitigation and continual improvement strategies.

Key Duties and Responsibilities:

• Responsible for oversight of the Compliance program, inclusive of Quality Events, CAPA, Investigations, and Escalations.
• Responsible for the facilitation and coordination, inclusive of developing and presenting compliance metrics, interpreting compliance trends, identifying areas of escalation, facilitating the meetings with senior level management representatives, and ensuring appropriate actions are taken.
• Key driver in risk assessment profile with the objective of ensuring transparency for gaining insights regarding state of compliance and adherence with quality standards/requirements across operational and areas providing strategic input to improvement initiatives for advancing operational excellence in quality.
• Partners with other Management area heads to ensure alignment of strategic and operational goals with priorities of the business and QA for delivery of results necessary
• Represents Vertex to various health authorities; gain acceptance and build trust externally as well as internally across various functions.
• Anticipates the impact of the changing domestic and international regulatory environment, exiting legislation and guidelines on the development of plans, implementation strategies and post-marketing maintenance.
• Provides leadership and management of monitoring of the external environment for leading practices, emerging trends and projection of future industry and capabilities requirements.
• Partners with key stakeholders for alignment in strategic and operational planning and delivery of business priorities and goals.
• Represents organization and serves as consultant, trusted advisor and partner to internal and external customers, partners, and stakeholders.
• Apply risk management principles to decision making and operational priorities.
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Highly collaborative and skilled at establishing effective working relationships with cross-functional groups and reaching common understanding on quality issues.
• Comfortable working in a demanding fast-paced, patient-focused organization, with start-up culture and evolving processes. Flexible and able to adapt to new situations as the business demands.
• Excellent verbal, written and presentation communication skills are essential.
• Experienced in pre-clinical, clinical, and chemical, manufacturing and controls (CMC) processes with demonstrated knowledge and application of quality and risk management approaches across GxP areas.
• A "doer" and individual willing to "roll up their sleeves" is key; flexibility to adapt to a start-up environment is required.
• Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause
• Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions.
• Ability to travel up to 15%.

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 12 years of experience in addition to 5 years of management experience or the equivalent combination of education and experience

We're enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Pay Range:
$0 - $0

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. 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