Manager, ESQA, CMO Quality (Americas)

Manager, ESQA CMO Quality Operations (Americas)

Reporting to the Senior Manager, External Supply Quality Assurance, the Manager, and External Supply Quality Assurance is responsible for managing and supporting global drug substance and drug product production efforts at Contract Manufacturing Organizations (CMOs) manufacturing. The Manager will work with CMO’s and cross-functional internal teams to transfer new processes, manage changes, resolve issues, deviations, and perform regular review of performance KPI’s.  The Manager may also lead process improvement or life cycle projects and may perform on-site support at CMO’s if needed.

This role is Global in nature and this individual will need to collaborate across the Global Quality Leadership Team as well as with CMO partners to assure that our Quality Assurance programs are implemented consistently across the network.

Responsibilities:

Responsible to partner with CMO to ensure strong business partnership with Quality team working to ensure Quality system alignment with CSL Behring and the External Supplier (CMO). Leads Quality related sub-projects in the corresponding relationship.

• Quality lead to support successful tech transfer of drug substance and drug product from one CMO to another
• Assure commercial readiness after tech transfer
• Escalate risks to key stakeholders and relevant functions .

Represents QA in cross-functional project teams such as External Supply Integration, tech transfer, and process improvements.

In collaboration with ESI, tracks CMO quality and escalates emerging trends to key stakeholders

• Identify CMO issues that present a trend through developing and implementation of robust KPIs in global standardized approach and External Supply Integration.
• Escalate emerging trends to key stakeholders and relevant global functions.
• Ensure that all operational areas are fully aware of results obtained and trends that are developing ensuring they can contribute to root cause investigations.

Continuously evolve the Global CMO Quality Program in alignment with standards provided by the External Supply Integration department.

• Design and implement a Global Quality Program for CMOs.
• Develop and maintain all CMO Quality program processes, quality agreements, qualification audits, policies, and SOPs wherever necessary.
• Drives the integration of the external supplier to our systems by ensuring standardization across systems (e.g. change management, PTC, recalls, deviation etc.).
• Assure training and development of global and site based CMO staff on the Quality Program: processes, policies, and SOPs.

Maintain knowledge of new/updated regulations and industry trends, with focus on gene therapy regulation.

• Understand new/updated regulations and track trends affecting CMO quality or compliance.
• Assure that CMO staff is educated on regulatory trends and implications.

Manages the activities of supplier (CMO) quality agreements, which include writing, editing, reviewing, updating, and routing the agreements for approvals between CSL Manufacturing Site, and suppliers (CMOs).

Participation and representation of Quality at joint meetings e.g. Operations, Business Review Meetings.

Lead Quality related topics at off-site visits and teleconferences for discussion and review of external supplier performance and cGMP compliance.

Provides personal in-plant assistance as necessary for contract manufacturing relationships.

Review/approve controlled cGMP documents including SOPs, material specifications, investigation protocols/reports, process validation protocols/reports, as applicable.

Act as the responsible person for CSL Behring to ensure all appropriate regulatory guidelines in the following areas are followed:

• Focusing on the management of authorized activities and the accuracy and quality of records.
• Ensuring that all GxP applicable personnel have an initial and continuous GxP training program which includes an overview of GxP, product identification, medicines and specific training for products requiring temperature control.
• Coordinating and promptly performing any recall operations for medicinal products together with the CSL responsible groups.
• Ensuring that relevant customer complaints are dealt with effectively together with the CSL responsible groups.
• Ensuring that suppliers and customers are approved.
• Approving any subcontracted activities which may have impact on GDP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
• Ensuring that any additional requirements imposed on certain products by national law are adhered to by the CMO and CSL.
• Acting as the SME for External Supply Quality Assurance organization in the dedicated cross-functional teams.

Education

Requires a four-year degree in a relevant business or science, or equivalent education and experience.

Experience

• Minimum of 5 years’ experience in a GxP environment in the pharmaceutical industry.
• Significant track record in the gene therapy business.
• Thorough understanding of required regulations including but not limited to FDA, PiC/S and European regulation, Therapeutics Goods Authority, Canadian Health Authority, etc.
• Strong industry and quality system knowledge (internal and external) experiences within the industry. 
•  Must be comfortable working in a global, matrix organization. Experience in CMO business highly preferred.

Competencies

• Strong organizational skills. 
• Managing diversity, time management and planning. 
• Cross-cultural sensitivity, perseverance, written and verbal communication. Directing others and delegation.
• Managerial courage, decision quality, functional and technical skills. Fluent in English (written and spoken).
• This role requires local and some (overseas) travel, 25% travel.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.