Clinical Quality Director

Employer
Xentria
Location
Working from Home
Posted
Nov 18, 2021
Ref
70
Required Education
Bachelors Degree
Position Type
Full time

Clinical Quality Director

Location: Anywhere in the U.S. (Remote Position) – about 10-20% of travel once pandemic restrictions are resolved.

The Clinical Quality Director, a position of Meitheal Pharmaceuticals, will lead Good Clinical Practice (GCP) activities, manage cross functional relationships with internal and external stakeholders, and be the lead Quality representative on clinical teams for ongoing clinical trials in support of Meitheal's specialty pharma division and shared services arrangements with Xentria Inc. Meitheal is a fully integrated R&D manufacturing and commercial company dedicated to supplying high quality, affordable products to the US healthcare market. Xentria is a patient-centric biotech company focused on novel biologics and biosimilars; its first program is XTMAB-16, a monoclonal antibody for sarcoidosis that received Orphan Drug Designation and is currently in a Phase 1 study.

Supervisory Responsibilities

No direct reports associated at this time.


Competencies

  • Interpersonal
  • Teamwork
  • Problem Solving
  • Quality Management
  • Judgement
  • Dependability
  • Ethics


Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


  • Strong knowledge of US and international GCP requirement practices, global regulations regarding clinical development, auditing and regulatory inspection is required.
  • Ability to work in a dynamic, start-up organization with aggressive timelines and multiple deliverables.
  • Must have professional communication skills, strong independent time management skills and the ability to manage multiple projects concurrently in an organized fashion.
  • Strong technical writing skills; ability to write clear quality positions statements, risk-based audit reports, and procedures.
  • Extensive experience in building GCP systems and processes.
  • Ability to travel up to 20% (domestic and international)

Education and/or Experience Required

  • Bachelor's degree in Clinical or Scientific discipline. Advance degree preferred.
  • Minimum of 10 years of experience in the pharmaceutical R&D industry, of which a minimum 8 years should be hands-on GCP Quality Assurance experience.


Computer Skills

Microsoft Word, PowerPoint and Excel. Technical software skills and experience, including ERP systems, Business Intelligence Tools, and experience optimizing data analytics to enact business decisions. 



Physical Demands

While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. 


Work Environment

The noise level in the work environment is usually moderate.

AAP/EEO Statement

Equal Opportunity Employer Minorities/Women/Veterans/Disabled. 

Essential Duties and Responsibilities

Essential Duties and Responsibilities include the following (other duties may be assigned):

• Provides expertise and guidance on GCPs and applicable regulations to specialty pharma/clinical development teams to proactively identify compliance issues/risks and recommend mitigation.

• Writes, reviews and revises SOPs related to clinical trials according to applicable global GCP regulations.

• Maintains the Quality Management System (QMS) for all SOPs and other controlled documents for specialty pharma.

• Develops and facilitates GCP/GXP training for functional areas and personnel involved in the execution of clinical trials.

• Leads regulatory inspection preparation activities and provides leadership and oversight during GCP inspections.

• Develops and implements risk-based GCP audit and compliance strategy.  

• Supports creation of QA audit schedule for vendors, service providers and clinical sites in support of clinical trials.  

• Assesses impact of audit findings and other identified compliance risks to subject safety, data integrity, and business operations.

• Reviews and provides input to clinical documentation (e.g. protocols, study reports, IBs, etc.).

• Leads investigations into significant quality issues, scientific misconduct and suspected breaches of GCP; facilitates identification of root cause and development of corrective/preventive actions; tracks actions and confirm effectiveness; ensures reporting of potential or confirmed violations to regulatory authorities, as appropriate.

• Supports internal audits and process audits of GCP areas, as needed.