Regulatory affairs associate Jobs in McKinney, TX

Support direct management in developing and operationalizing the inspection readiness plan within PPD.

Coordinate all phases of the inspection readiness plan and collaborate with team members from various therapeutic areas and clients to plan and execute inspection readiness activities.

Provide support within the Regulatory Inspection and Client Audits (RICA) department to host and / or coordinate HA Inspections at PPD and all related activities.

Assist management in planning and conducting Mock Inspections as assigned and / or contracted by clients.

Pull, analyze, and maintain related inspection metrics and trends; support the manager in managing the status of positive areas and those showing improvements required.

Support the clinical and other functional areas in risk assessment activities pertaining to study, site, or process to identify areas of increased risk to studies, programs and processes.

Evaluate signals and trends from Root Causes and ensure the commitments with HA are fully tracked by the actioned owners.

Support QA Inspection preparation models as contracted by clients.

Review findings responses (CAPA) to HA Inspections for adequacy to address non-compliance and minimize risks to the business.

Job Qualifications :

Education And Experience :

Bachelor's degree required.

Solid knowledge and experience related to FDA / Competent Authority inspection methodologies, FDA risk assessments, non-conformance interpretation / management, regulatory reporting requirements, and regulatory enforcement activities.

Solid understanding of GCP, experience in ICH-E6 and other regulatory requirements

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience

5+ years of previous experience in hosting, supporting or coordinating FDA or other Health Authority (HA) related GCP or Pharmacovigilance inspections.

Previous experience in clinical QA or clinical compliance related functions desired.

Previous people or project management responsibility preferred.

Knowledge, skills and abilities :

Solid drug development and quality management related knowledge.

Effectively collaborate and align QA with clinical operations and other functional areas.

Excellent oral and written communication skills.

Strong problem-solving, risk assessment, and impact analysis abilities.

Familar with and experienced in the root cause analysis process of a CAPA.

Previous strong eperience in developing and reviewing CAPAs in response to client audits or HA Inspections.

Experience in process improvement.

Strong negotiation and conflict management skills.

Familiarity with QA information management systems.

Flexible and able to multitask and prioritize competing demands / workload.

Ability to think independently and influence when appropriate.

Work may involve travel within the USA and other countries to attend HA inspections.

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.