Quality Assurance Manager

Industry

Health and Safety

Advert ID

USA_450142

Location

Bethesda

Job Type

Permanent

Hours

Full-Time

Salary Range

USD90000-110000 per year

No. of Openings

1

Branch Information

Bethesda, MD - (USA) 4800 Hampden Lane Suite 200 MD Bethesda , MD - 20814 Phone : 301-215-6346

ContactNumber

301-215-6346

Job Description

QUALITY ASSURANCE MANAGER (1 position)



RESPONSIBILITIES

*Plan and lead GCP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks.

*Assess GCP compliance risk areas and develop and implement risk mitigation measures.

*Ensure compliance with company's procedures and regulatory requirements.

*Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports).

*Review and provide input in to non-clinical documentation (e.g. protocols, study reports).

*Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies.

*Participate in the evaluation and selection of "CROs and other clinical and nonclinical service providers.

*Provide guidance, interpretation and information on GCP regulations, standards and quality systems.

*Develop and implement standards, policies and procedures for GCP regulatory compliance.

*Develop and measure quality metrics to drive consistent quality standards relating to GCP activities.



REQUIREMENTS

*Master's Degree preferred with minimal 10 years' experience in Biotech or Pharma and 5+ years' experience in Quality Systems related to GCP.

*Certified Quality Auditor preferred.

*Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement.

*Extensive experience auditing clinical CRO's, clinical sites and investigator sites.

*Understanding of domestic and international regulatory requirements.

*Outstanding communication skills (interpersonal, verbal and written).

.Proven track record of industry success.

*Strong leadership and management skills.



ADDITTIONAL INFORMATION

*GCP is a mandatory requirement, GMP is not considered, at all

*resume must state specific GCP experience/knowledge

*Travel - on-site locations and/or hospitals

*Mandatory shots/vaccinations required to enter the countries they will be traveling to - only what is required for entry to the country. We do not require anything, at the time of employment. Some of our domestic sites will ask for evidence of a flu vaccination to enter certain areas of the clinics.