IQVIA GLP Quality Audit Program Lead in Marietta, Georgia

Description:

Do you want to advance your career in biopharmaceutical Quality Assurance by applying your leadership skills in our GCP/GLP regulated BioAnalytical / Immunoassay laboratory? We are looking for a proven GLP QA professional who can build effective working relationships with scientific staff to enhance our culture of quality and continuous improvement.

PURPOSE

Implement quality audit program for regulated laboratory analysis in support of customer applications to global health authorities for new therapeutic products. Plan, lead and report results of independent audits to assess compliance with regulations, guidelines, and operating procedures. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support senior management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

RESPONSIBILITIES

  • Lead audits of regulated immunoassay studies in support of clinical and nonclinical studies. Audits are conducted to assess compliance with applicable Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations/guidelines, customer requirements, Q 2 Solutions’ SOPs and project specific guidelines/instructions.

  • Lead study and process inspections of critical bioanalytical phases of non-clinical and clinical studies.

  • Evaluate audit/inspection findings and prepare and distribute reports to operations staff, management, and customers.

  • Provide interpretation and consultation to scientific staff on regulations, guidelines, compliance status, and policies and procedures.

  • Provide consultation to customers in interpretation of audit observations and formulation of corrective and preventive action plans.

  • Review and approve corrective action plans

  • Develop and present educational programs related to quality and regulatory compliance.

  • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.

  • Host customer audits, and working with operations colleagues, develop corrective action plans.

  • Assist in hosting regulatory inspections

  • Represent QA in multifunctional projects related to continuous improvement or processes and systems.

  • Train new Quality Assurance staff as required

Qualifications:

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Extensive knowledge of pharmaceutical research and development processes and regulatory requirements especially as they relate to laboratory environments

  • Strong working knowledge of quality assurance processes and procedures, specifically as they relate to GLP. GMP knowledge also acceptable.

  • Working knowledge of FDA and global regulatory guidance as they relate to bioanalytical method validation and Watson LIMS software preferred.

  • Demonstrated communication, interpersonal and leadership skills.

  • Excellent problem solving, risk analysis and negotiation skills.

  • Strong training capabilities.

  • Effective organization, communication, and team orientation skills.

  • Ability to initiate assigned tasks and to work independently.

  • Ability to manage multiple projects and complete assigned audit tasks in a timely fashion in a high-throughput laboratory environment

  • Ability to establish and maintain effective working relationships with coworkers, managers and clients

  • Knowledge of word-processing, spreadsheet, and database applications.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

  • Bachelor’s/primary degree, preferably in a science or engineering field

  • 5 years experience in pharmaceutical, technical, or related area

  • 3 years in Quality Assurance; GLP or GMP experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS

  • Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for prolonged periods of time

  • Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of speech

  • Some travel required, may include international travel.

EEO Minorities/Females/Protected Veterans/Disabled

EEO Minorities/Females/Protected Veterans/Disabled

Job Field:

Quality

Primary Location:

USA-Georgia-Marietta