NCBiotech
Manager, Audits and Supplier Management
NCBiotech, Raleigh, North Carolina, United States, 27601
Overview
Based in the Raleigh, NC Corporate office - Hybrid
Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. We’re embarking on a transformative journey, blending time-honored traditions with exciting new products. As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good while growing together as a family.
If you’re looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we’re looking for YOU! #IAmMerz
Are you ready to galvanize a team around a culture of care, putting patients first to spark change?
The Manager, Audits and Supplier Management will be responsible for further development and oversight of the Supplier Management Program and Internal Auditing Program. The role will be the liaison to global Quality functions and will focus on compliance of operations with quality related requirements set by authorities and Merz-internal. This role is based in Raleigh but helps serve a Quality Assurance team responsible for North America (Canada and USA).
Responsibilities
Supplier Management
Oversee and contribute to the Supplier Management program through supplier qualification activities, supplier audits, maintaining contracts, monitoring supplier performance, monitoring, tracking and investigating supplier deviations and issuing SCARs where required
Maintain the audit schedule
Perform on-site/remote audits
Manage contracts (creating, revising, maintaining Quality Assurance Agreements, Wholesale Quality Agreements, etc.) and budget with local quality vendors
Raise vendor Change Controls in the company system
Train new hires onboarded into the Supplier Management team
Internal Audit Program
Oversee the internal audit program
Own the internal audit schedule
Perform internal audits
Serve as main contact for corporate audits
Inspections
Lead local contact for authority inspections, supporting all Merz sites globally with requests for information from an authority inspection
Quality Assurance Diligence
Adhere to QA key performance indicators (deviation investigations and closure, CAPA actions and closure, Change Control actions and closure, etc.)
Author/review SOPs
Contribute to Quality Management Reviews and quality team meetings
Collaborate with local and global quality, safety, regulatory teams
Participate in cross-functional projects, drive quality improvements, and foster a culture of quality through training and quality initiatives
Maintain compliance with Global Therapeutics Quality Management Systems
Additional responsibilities as assigned
Support local leadership in quality objectives as applicable
Stay up to date on SOP reading/training requirements
Notify manager of regulatory compliance questions and issues; back up team members as needed
Education and Certifications
Bachelor's degree in a Scientific discipline (Health Science, Science, Biology, Chemistry, Pharmacy, or related field) is required
Quality Auditor Certification is required
Professional Experience
At least 6-9 years of drug pharmaceutical quality assurance experience in a role directly involved with supplier auditing
Experience conducting pharmaceutical supplier (CMOs, 3PLs, laboratories, etc.) audits as a lead auditor is required
Experience hosting or participating in at least one authority inspection as a subject matter expert is required
Well versed in auditing principles and audit report writing
Investigation and closure of complex deviations, management of CAPAs and Change Controls, and SOP ownership
Experience issuing a supplier corrective action (SCAR) and follow-up/closeout is an asset
Knowledge of GMP, US Food and Drug Regulations, ISO 9001 required
Experience using SAP or another ERP system for supplier management is an asset
Experience using electronic quality management systems such as JIRA, Master Control, Veeva, etc. is an asset
This role is a manager of a process—no prior people management experience required
Knowledge, Skills, and Abilities
Well versed in drug GMP regulations; knowledge of EU and USA GMP considerations is an asset
Fluency in English with strong writing skills and ability to articulate quality concepts
Ability to juggle multiple items, prioritize effectively, and meet KPIs
Self-motivated with a can-do attitude and solution-oriented mindset
Strong critical thinking and decision-making skills
Team player who collaborates across sites
Willingness to work with diverse backgrounds, attitudes, and cultures
Travel Requirements
This role requires routine travel, including overnight stays, within the USA and Canada for supplier site audits; at least one trip per quarter
Possible trip to the German headquarters once every other year
Equal Opportunity Don’t meet every single requirement? We encourage you to apply anyway. Merz Therapeutics is committed to diversity, inclusion, and authentic workplace culture.
Recruitment Note: Merz Therapeutics only sends emails from verified merz.com addresses and never asks for sensitive information or money. If you have doubts about authenticity, contact Therapeutics.HR@merz.com
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For information, review the Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr
Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. We’re embarking on a transformative journey, blending time-honored traditions with exciting new products. As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth with the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good while growing together as a family.
If you’re looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we’re looking for YOU! #IAmMerz
Are you ready to galvanize a team around a culture of care, putting patients first to spark change?
The Manager, Audits and Supplier Management will be responsible for further development and oversight of the Supplier Management Program and Internal Auditing Program. The role will be the liaison to global Quality functions and will focus on compliance of operations with quality related requirements set by authorities and Merz-internal. This role is based in Raleigh but helps serve a Quality Assurance team responsible for North America (Canada and USA).
Responsibilities
Supplier Management
Oversee and contribute to the Supplier Management program through supplier qualification activities, supplier audits, maintaining contracts, monitoring supplier performance, monitoring, tracking and investigating supplier deviations and issuing SCARs where required
Maintain the audit schedule
Perform on-site/remote audits
Manage contracts (creating, revising, maintaining Quality Assurance Agreements, Wholesale Quality Agreements, etc.) and budget with local quality vendors
Raise vendor Change Controls in the company system
Train new hires onboarded into the Supplier Management team
Internal Audit Program
Oversee the internal audit program
Own the internal audit schedule
Perform internal audits
Serve as main contact for corporate audits
Inspections
Lead local contact for authority inspections, supporting all Merz sites globally with requests for information from an authority inspection
Quality Assurance Diligence
Adhere to QA key performance indicators (deviation investigations and closure, CAPA actions and closure, Change Control actions and closure, etc.)
Author/review SOPs
Contribute to Quality Management Reviews and quality team meetings
Collaborate with local and global quality, safety, regulatory teams
Participate in cross-functional projects, drive quality improvements, and foster a culture of quality through training and quality initiatives
Maintain compliance with Global Therapeutics Quality Management Systems
Additional responsibilities as assigned
Support local leadership in quality objectives as applicable
Stay up to date on SOP reading/training requirements
Notify manager of regulatory compliance questions and issues; back up team members as needed
Education and Certifications
Bachelor's degree in a Scientific discipline (Health Science, Science, Biology, Chemistry, Pharmacy, or related field) is required
Quality Auditor Certification is required
Professional Experience
At least 6-9 years of drug pharmaceutical quality assurance experience in a role directly involved with supplier auditing
Experience conducting pharmaceutical supplier (CMOs, 3PLs, laboratories, etc.) audits as a lead auditor is required
Experience hosting or participating in at least one authority inspection as a subject matter expert is required
Well versed in auditing principles and audit report writing
Investigation and closure of complex deviations, management of CAPAs and Change Controls, and SOP ownership
Experience issuing a supplier corrective action (SCAR) and follow-up/closeout is an asset
Knowledge of GMP, US Food and Drug Regulations, ISO 9001 required
Experience using SAP or another ERP system for supplier management is an asset
Experience using electronic quality management systems such as JIRA, Master Control, Veeva, etc. is an asset
This role is a manager of a process—no prior people management experience required
Knowledge, Skills, and Abilities
Well versed in drug GMP regulations; knowledge of EU and USA GMP considerations is an asset
Fluency in English with strong writing skills and ability to articulate quality concepts
Ability to juggle multiple items, prioritize effectively, and meet KPIs
Self-motivated with a can-do attitude and solution-oriented mindset
Strong critical thinking and decision-making skills
Team player who collaborates across sites
Willingness to work with diverse backgrounds, attitudes, and cultures
Travel Requirements
This role requires routine travel, including overnight stays, within the USA and Canada for supplier site audits; at least one trip per quarter
Possible trip to the German headquarters once every other year
Equal Opportunity Don’t meet every single requirement? We encourage you to apply anyway. Merz Therapeutics is committed to diversity, inclusion, and authentic workplace culture.
Recruitment Note: Merz Therapeutics only sends emails from verified merz.com addresses and never asks for sensitive information or money. If you have doubts about authenticity, contact Therapeutics.HR@merz.com
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer is required to notify all applicants of their rights pursuant to federal employment laws. For information, review the Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr