Vendor Quality Oversight Senior Specialist
Vendor Quality Oversight
Senior Specialist,
Major
Responsibilities:
Accountable for implementation and management of the global vendor quality oversight program. Managing a portfolio of vendors. Facilitate vendor qualification activities working with operational stakeholders. Escalate vendor quality issues and risks to management. Coordinate vendor qualification and audit schedules. Escalate and present vendor quality risks to the Local Quality Council and Global Quality Council. This position is responsible for managing the following supplier management tools and processes to ensure compliance to standards and processes; performance metrics (scorecard), vendor corrective actions, change requests, certifications, approved vendor supplier list, and records management.
Ensure designated vendors are audited on a regular basis to ensure regulatory and quality standards are met. Document risk assessments of vendors quality systems by means of on-site audits, questionnaires or other tools to assure the quality and conformity of supplied materials/services. Participate in vendor audits. Ensure vendor management practices reflect current regulatory and industry expectations. Provide subject matter expertise on vendor management practices during client audits. Maintains an active dialog and communication with appropriate teams to ensure progress and milestone success.
Qualifications:
Required:
Bachelor’s level degree with 7+ years experience in GXP environment, namely GMP, GCP, GLP. Strong attention to detail. Exceptional communication skills, both written and verbal. Demonstrated ability to work independently as well as part of a team. Ability to build effective relationships at all levels of the organization. Strong interpersonal and negotiation skills to succeed in a matrix environment. Allows remote work within the United States
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.Apply Now
Apply Now
Senior Specialist,
Major
Responsibilities:
Accountable for implementation and management of the global vendor quality oversight program. Managing a portfolio of vendors. Facilitate vendor qualification activities working with operational stakeholders. Escalate vendor quality issues and risks to management. Coordinate vendor qualification and audit schedules. Escalate and present vendor quality risks to the Local Quality Council and Global Quality Council. This position is responsible for managing the following supplier management tools and processes to ensure compliance to standards and processes; performance metrics (scorecard), vendor corrective actions, change requests, certifications, approved vendor supplier list, and records management.
Ensure designated vendors are audited on a regular basis to ensure regulatory and quality standards are met. Document risk assessments of vendors quality systems by means of on-site audits, questionnaires or other tools to assure the quality and conformity of supplied materials/services. Participate in vendor audits. Ensure vendor management practices reflect current regulatory and industry expectations. Provide subject matter expertise on vendor management practices during client audits. Maintains an active dialog and communication with appropriate teams to ensure progress and milestone success.
Qualifications:
Required:
Bachelor’s level degree with 7+ years experience in GXP environment, namely GMP, GCP, GLP. Strong attention to detail. Exceptional communication skills, both written and verbal. Demonstrated ability to work independently as well as part of a team. Ability to build effective relationships at all levels of the organization. Strong interpersonal and negotiation skills to succeed in a matrix environment. Allows remote work within the United States
Invicro is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.Apply Now
Apply Now