Randstad US Jobs

pv operations - capa manager.

• cambridge , massachusetts (remote)

• posted june 13, 2024

job details

summary

• $70 - $80 per hour

• contract

• bachelor degree

• category life, physical, and social science occupations

• reference48300

job details

job summary:

The CSPV CAPA Manager is responsible for overseeing and managing the investigation of CSPV Quality Events and the implementation of corrective and preventative actions (CAPA) within the organization. This role ensures compliance with industry standards and regulatory requirements, aiming to ensure high-level patient safety data and that patient safety obligations are met.

location: Cambridge, Massachusetts

job type: Contract

salary: $70 - 80 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

• Oversee and ensure high-quality, detailed analysis of deviations and CAPAs in cooperation with vendors, external partners, and internal company colleagues.

• Lead investigation for all deviations/issues from all sources to ensure robust root cause investigation and corrective and preventative actions.

• Ensure implantation and tracking of CAPAs in collaboration with multiple functions within the company (PV, Regulatory, Medical, Commercial, etc.) and external to the company (i.e., business partners, vendors, etc.).

• Investigation Management: Lead investigations into non-conformances, deviations, and other quality issues. Coordinate with cross-functional teams to determine root causes and impact assessments. Ensure investigations are documented accurately and completed within required timelines.

• CAPA Management: Develop and implement corrective and preventative actions to address identified issues. Maintain CAPA records and documentation in compliance with regulatory standards.

• Vendor Deviation Oversight: Responsible for closely partnering with the company's vendors to ensure the quality of deviation investigations and CAPAs

• Support compliance monitoring activities for pharmacovigilance in collaboration with stakeholders.

qualifications:

• Bachelor's degree (preferably in a science or health-related field) and a master preferred

• A minimum of 7 years of experience in Pharmacovigilance, Regulatory, Clinical, Quality Assurance with a comprehensive understanding of Pharmacovigilance Operations

• Must have experience in quality and deviation management and CAPA management

• Knowledge of pharmacovigilance and regulations

• Strong communication and ability to partner closely and effectively cross-functionally and cross-regionally

• Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes

• Excellent interpersonal skills, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs, and recommendations

• Excellent analytical skills and an ability to communicate complex issues in a simple way

• Ability to manage multiple, complex topics in a fast-paced environment

skills: Pharmacovigilance, CAPA

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.