Senior Director Operations

Job Overview

A Senior Director, Operations is responsible for providing oversight of and leadership for applicable operational groups. The individual in this role is also responsible, as part of the site leadership team, for guiding the development of the site’s strategic and tactical planning so that a full line of quality products and services is managed in response to customer and industry needs. May be delegated certain test facility management (TFM) responsibilities, as applicable.

Essential Duties and Responsibilities

• Define, lead, and execute a comprehensive In-Life and Post-Life Operations strategy, in context of the global Charles River DSA vision.
• Supervisory responsibilities in accordance with the organization’s policies and applicable laws to include workforce planning, interviewing, hiring, training, and developing employees; planning, assigning, and directing work; appraising performance and completing annual performance review on or before due date; rewarding and disciplining employees; investigating and addressing complaints; and resolving problems.
• Contribute, as a member of the site leadership team, in the development of strategies and tactics to support the mission, vision, values, resourcing, and performance objectives of the site and company.
• Provide leadership for business development, developing and maintaining working relationships with key clients, agencies, and global stakeholders.
• Verify compliance with regulatory requirements, guidelines, and best practices; mentor staff, sharing scientific, organizational, and operational expertise.
• Provide leadership and support to cross-functional teams that work toward enabling successful investigational new drug (IND) applications or new drug application (NDA) submissions.
• Inform internal and external stakeholders of strategy, plans, and changes as needed to provide quality products and services.
• May be delegated certain TFM responsibilities applicable (see detailed role and responsibilities of TFM below).

Test Facility Management Responsibilities

• May Include Designate a qualified Study Director (SD) before the study is initiated.
• Verify documented approval of the study plan/protocols by the SD.
• Verify that approved study plan/protocol is available to the quality assurance unit (QAU).
• Verify that deviations from Good Laboratory Practices (GLPs) are communicated to the SD and corrective actions are taken and documented.
• Verify that test and reference items/test and control articles or mixtures have been appropriately tested.
• Verify that personnel are able to perform the functions assigned and, where necessary, provide training for these functions.
• Verify maintenance of record of the qualifications, training, experience, and job descriptions for personnel.
• Verify that appropriate and technically valid SOPs to support study personnel responsibilities are established and followed and approve all original and revised SOPs and verify the maintenance of a historical file of SD responsibilities.
• Verify, if the conduct of phases of a study are delegated (i.e., a multi-site study), that a Principal Investigator (PI)/Individual Scientist (IS) is designated, who is appropriately trained, qualified, and experienced to supervise the delegated phase(s) of the study and that replacement of a PI is done according to established procedures, and is documented.
• Verify, if the conduct of phases of a study are delegated (i.e., a multi-site study), that clear lines of communication exists between the SD, PI(s)/IS(s), the QAU(s) and study personnel.
• Reviews and approve the study plan/protocol if required by national GLP regulations.

Compensation Data

The pay range for this position is $170,000/yr - $212,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Minimum Qualifications

• Education and Experience: Bachelor’s degree (Master’s or Doctorate degree preferred) with 20 or more years of relevant experience in biomedical research and at least 15 years in leadership roles with at least 7 years of senior leadership experience; contract research organization experience preferred.
• Demonstrated ability to solve problems, make quick decisions, communicate decisions effectively, and lead/manage staff in a growing, changing environment.
• Demonstrated knowledge of GxPs and industry guidance documents.
• Ability to communicate verbally and in writing at all levels inside and outside the organization.
• Basic familiarity with Microsoft Office Suite.
• Computer skills, commensurate with Essential Duties and Responsibilities, including the ability to learn a validated system.
• Ability to work extended hours beyond normal work schedule to include, but not limited to evenings, weekends, extended shifts, and/or extra shifts, sometimes on short notice.
• Ability to work under specific time constraints.