Sr. Director/Exec Director QA, Inspection Preparedness Lead
Provides strategic direction, leadership and management across PPD's global quality and compliance functions, including internal audits, issue management, vendor audit management, regulatory inspections, client audits and Phase I / early development services. Develops QA plans and provides counsel on guidelines and regulations. Manages staff, assigns work, and reviews workload for all direct reports. Establishes goals, coaches and trains employees to increase knowledge and skill levels. Recommends and approves courses of action on all management / human resources' matters. Identifies areas of regulatory risk and brings to the attention of management for resolution development Produces and implements remedial action plans Maintains quality related operational metrics and communicates with management the status of positive areas and those showing improvements needed Provides counsel on all aspects of GxP QA related guidelines and regulations Develops and adheres to a quality plans and closely collaborates with operational leadership to assure an overall high level of quality for all Laboratory QA Assists in business development through assuring readiness for all client and regulatory audits Responsible for evaluating PPD process and systems through mock inspection and techniques Analyze available performance and quality data to identify potential areas of risk QMS Project Management of agreed actions to address deficiencies from mock inspection and trend analysis activities Contractable resource for Sponsor/CRO mock inspections Contractable inspection management support This role will be an additional reviewer/advisor/resource to existing GQC teams (QIS, RICA) Provides support and feedback for Reg Authority inspections of PPD. Reviews Regulatory Authority inspection reports to evaluate findings for risks to PPD, root cause analysis, and action generation. Reviews Regulatory Authority inspection responses for adequacy to address non-compliance and minimizing risks to the business. Consults with QA and management on SSM investigation and interpretation. LI-LC1 LI-Remote
Qualifications:
Education and
Experience:
Bachelor's degree required. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 to 15
years) or equivalent and relevant combination of education, training, & experience. 5 to 10
years of management responsibility. 5-10 years previous employment by FDA as GxP investigator with strong experience in GCP required. Participation in joint Competent Authority inspections/initiatives preferred.Knowledge, Skills and Abilities:
Excellent knowledge of Quality Assurance methods Thorough knowledge of GxP Strong management and leadership skills Demonstrated ability to collaborate and align QA with operations Excellent oral and written communication skills Experience in writing and reviewing Standard Operating Procedures Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Solid experience in CAPA review Demonstrated experience in process improvement Strong negotiation and conflict management skills Familiar with QA information management systems Flexible and able to multi-task and prioritize competing demands/work load Ability to think independently and influence when appropriate Detailed knowledge of FDA/Competent Authority inspection methodologies, FDA risk assessments, non-conformance interpretation/management, regulatory reporting requirements, and regulatory enforcement activities.Working environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel.(Recruiter will provide more details.) As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Qualifications:
Education and
Experience:
Bachelor's degree required. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10 to 15
years) or equivalent and relevant combination of education, training, & experience. 5 to 10
years of management responsibility. 5-10 years previous employment by FDA as GxP investigator with strong experience in GCP required. Participation in joint Competent Authority inspections/initiatives preferred.Knowledge, Skills and Abilities:
Excellent knowledge of Quality Assurance methods Thorough knowledge of GxP Strong management and leadership skills Demonstrated ability to collaborate and align QA with operations Excellent oral and written communication skills Experience in writing and reviewing Standard Operating Procedures Strong problem solving, risk assessment and impact analysis abilities Solid experience in root cause analysis Solid experience in CAPA review Demonstrated experience in process improvement Strong negotiation and conflict management skills Familiar with QA information management systems Flexible and able to multi-task and prioritize competing demands/work load Ability to think independently and influence when appropriate Detailed knowledge of FDA/Competent Authority inspection methodologies, FDA risk assessments, non-conformance interpretation/management, regulatory reporting requirements, and regulatory enforcement activities.Working environment:
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel.(Recruiter will provide more details.) As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
Salary Range:
$200K -- $250K
Minimum Qualification
Quality ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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