Manager, CMO Quality EMEA

For our site in St.Gallen we are looking for a

Manager CMO Quality EMEA

Reporting to the Senior Manager CMO Quality EMEA, the Manager, CMO Quality EMEA 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, Bulk, Fill/Finish, Packaging). Focus of this QA role is to work on a regional basis (EMEA) with CMOs 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 CSL Quality in operational meetings and projects.  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

• 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.
• Initiates, manages (writing, editing, reviewing, updating, routing) and negotiates CMO Quality Agreements.
• Oversee, track and report CMO quality performance
• Escalate Quality issues and emerging trends to key stakeholders and relevant global functions.
• Maintain standardized Quality Oversight processes and governance with CMO and CSL Sites
• Represents QA in cross-functional project teams such as CMO Operations, commercial readiness, and process improvements.
• Quality Person-in-Plant – The CMO Quality Manager provides on-site presence at the CMO as necessary.
• Manage intake of new CMO Projects and Initiatives as required

Minimum Qualifications:

• Requires a four-year degree in a 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) experiences within the industry.
• Must be comfortable working in a global, matrix organization.
• Experience in CMO business highly preferred.
• Strong organizational skills.
• Fluent in English (written and spoken). German knowledge is a plus.

We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and/or diplomas in the original language. Please include all these in one document together with the CV.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.