Pay: $70-75/hr
Job Description:This role is responsible for developing strategic direction for quality support of BioTherapies operations and client services. You will assess, develop, and effectively manage quality systems and processes critical for BioTherapies and Collection Center, in collaboration with other QRA teams. You will also be responsible for ensuring inspection readiness and audit readiness, analyzing systems CAPA, change control, and deviations, making necessary changes, and providing recommendations for improvement.
Key Responsibilities:Work with senior leadership to develop and execute strategies to provide comprehensive quality support for operations groups, clients, and partners, in support of the organization’s strategic plan.Analyze, plan, and improve enterprise quality systems and compliance in collaboration with the Quality department and operations leaders.Provide expertise, guidance, and executional support to business partners, project teams, and clients.Plan, identify, and develop staffing needs for highly effective team performance.Lead quality system development and process improvement projects.Provide coaching, direction, and support for team members.Implement, evaluate, and improve the Quality Management System and key supporting processes to maximize efficiency and efficacy for operations.Coordinate preparation for and management of audits by regulators, accrediting agencies, and clients.Support and collaborate with other Quality leaders and process owners to develop consistent and integrated quality processes across the organization.Skills & Qualifications:10-15 years of GMP experienceExperience with CAPA and Quality Regulatory processesExperience with Diva QMS SystemIdeally, experience in the Cell and Gene Therapy industryPay and BenefitsThe pay range for this position is $70.00 - $75.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully remote position.
Application Deadline
This position will be accepting applications until Dec 30, 2024.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.