Job Description

Manager, Quality Management and Compliance

Location:

PhiladelphiaPennsylvania

Date Posted:

8/10/2022

Employment Type:

Permanent

Recruiter:

Mohamed Barami

Recruiter Email:

mo.barami@avidtr.com

Job ID:

JN -082022-15180

Job Description

Manager, Quality Management and Compliance
The Manager, Quality Management and Compliance will be responsible for oversight of the Company’s internal quality assurance activities, including continual audit-readiness, support for high-level sponsor and regulatory audits, vendor audits and direction and mentoring of other quality assurance and support personnel within Quality Management and Compliance group.  The Manager will interact with personnel throughout the Company as necessary to ensure compliance with all regulatory and clinical guidelines as well as company policies and procedures. 
Job Requirements
           Skills/Abilities
The Manager, Quality Management and Compliance role requires the following:
  • Exemplary interpersonal, communication (oral and written) and education skills
  • This role necessitates self-direction, motivation, organization, strict attention to detail and problem solving abilities are necessary

Experience
  • A minimum of five (5) years relevant Quality Assurance and/or Auditing experience in a clinical setting strongly preferred.
  • Prior experience in preparing for high-level sponsor or regulatory audits is required.
  • Prior experience in training and mentoring of other staff is strongly preferred.
  • Prior experience conducting vendor audits preferred.
  • A minimum of three (3) years’ experience working with clinical oncology trials strongly preferred.
  • Thorough understanding and experience in the clinical trial development process including knowledge of clinical trials in all phases.

Education
  • A bachelor’s degree from an accredited college or university or possession of relevant professional experience is required.
  • A Master’s degree in a related field is preferred.
  • Completion of a degree or certificate program in quality management or related training in clinical trial auditing is desirable.

Responsibilities
  • Internal Audit Readiness
    • Coordinates, performs and oversees internal quality audits to ensure compliance with regulations, agreements and Company policies and SOPs.
    • Maintains quality standards and ensures that studies, documents, and submissions to regulatory agencies meet required industry and agency specified standards.
    • Performs QA/QC document reviews and activities as required and necessary; where needed develops new documents.
    • Assists in development, management, and execution of audit programs & QA plans for clinical studies and functional areas of oversight.
  • Team Leadership
    • Provides training and mentoring to staff on subjects such as Good Clinical Practices (GCP), Good Documentation Practices (GDP), etc.
    • Leads the development of effective SOPs, Checklists, Templates, Quality Assurance Reports, Quality Assurance Plans and training materials.
  • Vendor Audits
    • Performs and oversees Quality Audits of vendors, partners and collaborators to ensure compliance with regulations, agreements and SOPs.
  • Organizational Support
    • Effectively and accurately documents audit findings by generating an audit report, or other Quality Assurance summaries and obtain responses in a timely fashion.
    • Provides advice and counsel to internal departments and personnel as needed.
    • Evaluates audit responses for compliance with applicable guidelines, regulations, and Standard Operating Procedures/Policies.
    • Recommends and discusses remediation plans and follows-up on plans as applicable until closure.


 
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