Senior Director, Quality Assurance and Compliance

Veristat
Full time
Business Management
United States
Hiring from: Anywhere

Senior Director, QA & Compliance



  • Quality Assurance & Compliance

  • Remote/National, United States


Description


Veristat is expanding our presence internationally from our home office outside Boston to Montreal, Toronto, Research Triangle Park, Michigan, Taiwan, and the United Kingdom.


We do things differently than large CROs. Do you value scientific integrity and a collaborative team environment? If so, you will feel right at home here with dedicated opportunities to discuss your achievements and grow your career through quarterly managerial conversations.


The Senior Director, Quality Assurance (QA) and Compliance is responsible for ensuring compliance with all relevant guidelines and regulations, overseeing quality management and training, ensuring that Veristat as a company has appropriate corporate policies, procedures, and infrastructure, and that staff are qualified to perform regulated tasks, and adhere to Standard Operating Procedures (SOPs).


The Senior Director, QA & Compliance is ultimately responsible for providing strategic direction and leadership to the department to best achieve departmental and company goals. In conjunction, s/he also participates as a member of the Senior Leadership Team.


As a Senior Director, QA & Compliance You Will…



  • Be responsible for the direct management of QA & Compliance managers and indirect management of all QA & Compliance staff, including performance management, career development & growth, training, and employee relations.

  • Be responsible for assessing hiring needs, interviews, and hires to align with the needs of the department.

  • Be responsible for performance & management of department financials: profit and loss (P&L), including participation in senior leadership meetings related to QA & Compliance.

  • Participate with senior management, develop and implement corporate policies and SOPs related to quality management/assurance and compliance for each functional department (e.g. project management, data management, biostatistics, medical writing).

  • Monitor the development, approval, periodic review, revision, version control and historical archival of all SOPs and supporting documents.

  • Review selected regulatory/clinical/technical documents (including but not limited to investigator/site regulatory documents, protocols, amendments, sample case report forms, statistical analysis plans) for quality and compliance with applicable regulations.

  • Direct the internal auditing function to ensure that the operations of all functional groups are in compliance with corporate SOPs and applicable regulations.

  • Under the direction of senior management, assist departments with external audit readiness including policy development, best practice sharing, and training/coaching.

  • Direct and participate in audits, both external (clients, vendors, regulatory) and internal.

  • Coach, develop, and mentor Quality Assurance (QA) employees. Allocate/re-allocate internal and external resources, as needed. Manage and establish priorities for the quality assurance staff.

  • Develop Veristat training standards and policies and assist with the development, implementation and administration of functional and cross-functional training materials.

  • Work with department heads to develop and consistently apply internal quality standards for documents and procedures.

  • Encourage problem-solving processes leading to solutions for leverage across departments. Ensure sharing of initiatives/ideas and accomplishments across these same groups.

  • Act as Data Privacy Officer (DPO) for Veristat.

  • Lead by example and model core values in all actions; ensure a positive, respectful team environment, fostering collaboration and development.


Experience + Requirements



  • Bachelor’s Degree in a science or related field required; Master’s Degree preferred.

  • 10 or more years of relevant industry experience in Quality Assurance/Compliance required, with at least 8 years of direct management experience. Experience managing a global team strongly preferred.

  • Expert knowledge of International Conference on Harmonisation (ICH), Food and Drug Administration (FDA), and other regulatory body guidelines, experience managing audits and/or FDA/European Union (EU) inspections.

  • Experience in participating in regulatory body inspections and inspection readiness activities with working experience in quality system programs of training, CAPA and document control.

  • Excellent written and oral communication skills, strong leadership and management skills, demonstrated ability to work in a cross-functional team environment, and demonstrated problem-solving ability and aptitude to process complex quality issues.

  • Expert in relevant regulations and guidelines including 21CFR-Part11, GCP, and QSIT.


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