BioSpace
Job Title
Sr Specialist Global Procurement – Compliance
Company BioSpace
Overview The Sr Specialist Global Procurement – Compliance will support the planning and execution of compliance initiatives utilizing the sourcing process for raw material manufacturers and distributors. The role supports and maintains all cGMP compliance aspects of Global Procurement operations under the direction of Sourcing Management.
On‑Site Requirement This role requires onsite 5 days / week and is not open to remote or hybrid arrangements.
Responsibilities
Supports and proactively maintains all Sourcing cGMP procedures, documentation and training related to SOP and Work Instructions.
Supports and maintains Approved Supplier List (ASL).
Supports compliance needs and coordinates with other sites to ensure engagement, feedback and buy-in related to Global Procurement document revisions.
Supplier Audit Compliance: Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
Coordinates with Cross-Functional Compliance resources to support Global Procurement and Quality Auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments.
Tracks and reports CAPA to support audit closure.
Executes cGMP compliance documents and supports cGMP activities among the Global Procurement team.
Supports and assists with the management of Supplier Corrective Action Reports (SCARs).
Works closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
Completes Global Procurement change controls to ensure they are done correctly and effectively.
Works with Global Procurement staff to review and drives timely closure of NOE / deviations and associated processes (CAPA).
Actions the Global Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.
Supports the Global Procurement staff as required for assigned categories and participates in other procurement office duties as assigned.
Qualifications
Excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
Understanding of cGMP systems and processes with a particular emphasis on compliance is strongly preferred.
Familiarity and experience working in an ERP system is preferred.
Ability to build strong relationships with stakeholders and suppliers to drive results.
Demonstrated success supporting cross-functional teams to drive results in SCARs, ASLs, CAPAs, Change Notifications, and related Quality and Compliance processes.
Working & operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement.
Continuous improvement mindset in identifying areas of improvements and working with leadership to implement them.
Required Experience BS/BA in a related field and at least 5 years of relevant experience in a cGMP environment, preferably in procurement or equivalent combination of education and experience. Work experience within a biopharmaceutical company preferred. Microsoft Office required including strong PowerPoint and Excel skills.
Salary $78,700 – $128,700 annually.
EEO Statement Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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Company BioSpace
Overview The Sr Specialist Global Procurement – Compliance will support the planning and execution of compliance initiatives utilizing the sourcing process for raw material manufacturers and distributors. The role supports and maintains all cGMP compliance aspects of Global Procurement operations under the direction of Sourcing Management.
On‑Site Requirement This role requires onsite 5 days / week and is not open to remote or hybrid arrangements.
Responsibilities
Supports and proactively maintains all Sourcing cGMP procedures, documentation and training related to SOP and Work Instructions.
Supports and maintains Approved Supplier List (ASL).
Supports compliance needs and coordinates with other sites to ensure engagement, feedback and buy-in related to Global Procurement document revisions.
Supplier Audit Compliance: Drives successful audit closures by focusing on proactive issue resolutions and communication with suppliers to effect acceptable audit closures for raw materials.
Coordinates with Cross-Functional Compliance resources to support Global Procurement and Quality Auditing needs for acceptable closure of audit findings and to secure evidence that substantiates supplier commitments.
Tracks and reports CAPA to support audit closure.
Executes cGMP compliance documents and supports cGMP activities among the Global Procurement team.
Supports and assists with the management of Supplier Corrective Action Reports (SCARs).
Works closely with Legal, QA and Suppliers to help facilitate the execution and management of various agreements, as required.
Completes Global Procurement change controls to ensure they are done correctly and effectively.
Works with Global Procurement staff to review and drives timely closure of NOE / deviations and associated processes (CAPA).
Actions the Global Procurement responses to compliance related requests for data from Regulatory, Quality Assurance, Audit staff and other stakeholders.
Supports the Global Procurement staff as required for assigned categories and participates in other procurement office duties as assigned.
Qualifications
Excellent collaboration skills and the ability to work cross functionally across categories and internal stakeholders.
Understanding of cGMP systems and processes with a particular emphasis on compliance is strongly preferred.
Familiarity and experience working in an ERP system is preferred.
Ability to build strong relationships with stakeholders and suppliers to drive results.
Demonstrated success supporting cross-functional teams to drive results in SCARs, ASLs, CAPAs, Change Notifications, and related Quality and Compliance processes.
Working & operating with integrity, focus, and clarity in an environment of ambiguity to drive change and improvement.
Continuous improvement mindset in identifying areas of improvements and working with leadership to implement them.
Required Experience BS/BA in a related field and at least 5 years of relevant experience in a cGMP environment, preferably in procurement or equivalent combination of education and experience. Work experience within a biopharmaceutical company preferred. Microsoft Office required including strong PowerPoint and Excel skills.
Salary $78,700 – $128,700 annually.
EEO Statement Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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