Senior Director, Business Operations Lead (Hybrid)

Vertex Inc.•Boston, MA

1d•Hybrid

About The Position

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.

Requirements

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%.
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

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.

Benefits

medical
dental
vision benefits
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)
annual bonus
annual equity awards