Manager, CMO Quality EMEA fluent in English and German

Reporting to the Head of CMO Quality, the Manager, CMO Quality is responsible for managing and supporting production efforts at Contract Manufacturing Organizations (CMOs) and to provide quality oversight for outsourced operational activities (e. g. API, Fill/Finish, Packaging). Focus of this QA role is to work on a regional basis (EMEA or Americas) with CMOs, support cross-business unit peers (CSL Behring, CSL Seqirus, CSL Vifor) and cross-functional teams to assure CMO Commercial Readiness (Tech Transfer) and CMO Operations. Core activities include developing and enforcing Quality Agreements, supporting CMO Changes and Deviations, resolving quality issues and reviewing of Quality Performance KPI's. The Manager may provide on-site support at CMO's if needed.

This position will represent and lead CSL Quality in Operational/Pre-Campaign Meetings. Relationship management with our key CMO partners is a core responsibility of this role.

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

Role and responsibilities

Interface:
Establish Collaborative Relationship with CMO and CSL MAH stakeholders (CMO Operations, Supply Chain, MAH Batch Release/QP) to ensure CMO Quality Oversight, Strong Quality System and Product Supply.

• Serves as primary regional interface and point of communication for assigned CMO's.
• As such, responsible to partner with CMO and MAH stakeholders to ensure strong business partnership and resolution of issues.
• Strives business continuity in partnership.
• Ensure CMO Quality system alignment with corresponding CSL site owner.
• Support operational effectiveness and partner with External Supply Operations.

Quality Contract:
CMO Quality Agreements

• Initiates, Manages (writing, editing, reviewing, updating, routing) and Negotiates CMO Quality Agreements.
• Ensure that all appropriate regulatory guidelines are represented in the Quality Agreement as well as oversee those from a day-to-day perspective:
  
  • Assure CMO is approved.
  • Execution of authorized activities and the accuracy and quality of records.
  • Maintain GxP training.
  • Support any recall operations for medicinal products together with the CSL responsible groups and the CMO.
  • Ensuring that relevant customer complaints are dealt with effectively together with the CSL responsible groups.
  • Deviation management and CAPA:
    Review, assess (by consulting relevant MAH SMEs), challenge and approve CMO deviations to ensure product quality and compliance. Continuously improve processes in order to prevent deviations and to increase quality and compliance standards.
  • Changes; Review, assess (by consulting relevant MAH SMEs), and respond to CMO changes; Share relevant information with MAH SMEs whenever CSL changes need to be initiated.
  • Review/approve controlled cGMP documents including SOPs, material specifications, investigation protocols/reports, process validation protocols/reports, as applicable.
  • Ensuring that any additional requirements imposed on certain products by national law are adhered to by the CMO and CSL.

Performance:
Oversee, track and report on regional CMO quality performance

• Develop, monitor and report CMO Quality performance through globally aligned KPIs.
• Identify CMO issues that present a trend.
• Ensure adequate corrective actions are implemented at the CMO.

Escalation:
Escalation Resolution

• Escalate Quality issues during Joint Operation Meetings.
• Escalate Quality issues and emerging trends to Sr. Manager, CMO Quality, key stakeholders and relevant global functions.
• In case of major CMO Quality issues, ensure that all required operational areas are fully aware of results and progress to ensure MAH can validate to root cause investigations and CAPAs.
• Provide decision support where necessary to the CMO and MAH Batch Release Team in response to issue management.

Standardization:
Maintain standardized Quality Oversight processes with CMO and CSL Sites

• Act with applied consistency of CMO Quality process and governance.
• Drives the integration of the CMOs to CSL's quality system governance by striving for harmonization across quality system handling (e. g. , change management, Product Technical Complaints, Batch Record Reviews, Recalls, Deviation etc. ) to ensure we work hand-in-hand.
• Follow standardization across CMOs (e. g Change Management, Product Technical Complaints, Batch Record Reviews, Recalls, Deviations etc. ) to ensure comparability btw. CMOs.

Quality Representative:
Represents QA in cross-functional project teams such as CMO Operations, commercial readiness, and process improvements.

• Acting as the SME for CMO Management organization in the dedicated cross-functional CSL teams.
• Participation and representation of Quality at joint Operational Meetings.
• Responsible for preparing the quality content for the Joint Business Review Meeting.
• Lead Quality related topics at off-site visits and teleconferences for discussion and review of CMO performance and cGMP compliance.
• Leads Quality related sub-projects within CSL and in connection with the corresponding relationship.

Quality Person-in-Plant:
Provides on-site presence as necessary.

• Lead the on-site resolution of Quality concerns at CMO Operations and CMO Commercial readiness phase.
• Enhance CMO Quality Maturity.
• Execute Quality Road Maps as necessary.
• Support CSL Product related regulatory inspections at the CMO as needed, assess and communicate any potential impact on CSL business.
• Support Regulatory Observations related to CSL product as necessary.

Future Growth:
Manage intake of new CMO Projects and Initiatives

• Provide commercial readiness (during Tech Transfer phase), product launches and submission support as necessary.

Manager:
Branding Responsibilities

• Be a respected manager acting consistent with the overall ESQ partnering strategy and culture.
• Maintains knowledge of new/updated regulations and industry trends and continuously monitors CMO quality and compliance towards those.
• Represent the CMO Q-Oversight function in authority inspections, corporate audits and self-inspections as assigned.
• Perform additional tasks as assigned.

Minimum Qualifications:

• B. S. degree in relevant business or science, or equivalent education and experience.
• Minimum of 5 years' experience in a GxP environment in the pharmaceutical industry.
• 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) ex.