Job Detail

About CSL

With operations in 35+ nations and ~ 22,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Stellenbeschreibung

For the site in Bern or Marburg and within the Supply Quality Management department, we are looking for an:

Associate Director, External Supply Quality

You will report to the Head of External Supply Quality Assurance, the Associate Director of External Supply Quality Assurance will oversee QA resources responsible for partnering with CMO (Contract Manufacturing Organization) /third party manufacturers/supplier program across the CSL network.

This is a strategic supply arrangement for CSL and the focus of the role is to assure adherence to the Quality Assurance program, Qualification Audits, Quality Agreements, processes, GMP requirements and SOPs. You will manage a small global team located at each applicable site who serve as the QA point of contact with these third parties for quality related issues and will strive to create streamlined global processes and SOPs that are consistent across sites and third-party adherence in terms of quality related issues.

This role is Global in nature and you 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

Global CMO Oversight

• Provide global oversight over CMO vendors to assure they adhere to the CSL Quality requirements, ensuring support for critical operations where appropriate


• Provide support to the site based CMO staff and dedicated cross-functional teams in terms of quality related issues or deviations. Analyze the issues to ensure full understanding and the risk to CSL products. Provide guidance where necessary to the third party organization in response to issue management


• Establish strong stakeholder relationships with the quality organization of current and future CMOs


• Escalate any significant third party quality issues to CSL Quality leadership and ensure corrective actions and working closely together with External Supply Integration department


• Oversee any regulatory inspections and assess any potential impact on CSL business


• Utilize risk assessment tools to assess potential new CMOs and prioritize existing CMOs


• Support Escalation Issues within the External Supply Integration Governance e.g. Business Review Meeting.

Design and Implement Global CMO Quality Program in alignment with 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.


• Ensuring that the integration of the external supplier to our systems are guaranteed by driving standardization across systems (e.g. Change Management, PTC, Recalls, and Deviation etc.).


• Assure training and development of site based CMO staff on the Quality Program: processes, policies, and SOPs

Track CMO quality and escalate 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

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

• Ensuring that the interfaces of the quality management systems between the supplier and CSL is implemented and maintained


• Focusing on the management of authorised activities and the accuracy and quality of records


• Ensuring that all GxP applicable personnel have an initial and continuous GxP training programme which includes an overview of GxP, product identification, the risks of falsified medicines and specific training for products requiring temperature control


• 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 impact on GDP


• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place


• Deciding on the final disposition of returned, rejected, recalled or falsified products


• Ensuring that any additional requirements imposed on certain products by national law are adhered to by the CMO and CSL


• Acting as the Business Partner for External Supply Quality Assurance Organization.

Provide CMO Oversight team leadership

• Provide leadership and guidance to region-based CMO Oversight teams to effectively execute on Quality Assurance strategies and programs.


• Set objectives and provide clear direction for execution.


• Responsible for organizational design and staffing decisions.


• Recruit, retain, train and develop the team.


• Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.

Implements strategic goals established by functional leadership.

Responsible for fiscal year budgetary planning, ongoing forecasting and business case development for justification of year-on-year financial change within the responsible area.

Through succession planning, create, institute and follow-up on individual development plans for each direct report which cultivates individual and organizational bench-strength.

Your Profile

• Minimum 3 years’ experience in leading a team.  Minimum of 7 years’ experience in a GxP environment in the pharmaceutical industry with broad knowledge in CMO businesses.


• Thorough understanding of required regulations including but not limited to FDA, PIC/s and European regulation, Therapeutics Goods Administration, Canadian Health Authority, etc. Strong industry knowledge and auditing knowledge (internal and external) experiences within the industry.


• Must be comfortable working in a global, matrix organization.


• Good understanding of the importance and use of quality metrics.


• 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). Non-English language skills (especially German, Spanish or Mandarin) beneficial.


• This role requires local and some overseas travel, in total about 25% travel.


• Proficient in building consensus and escalating issues.


• Excellent communication and organizational skills, as well as negotiation, influencing and collaboration skills.


• Demonstrated ability to work cross-functionally across internal and external stakeholders.


• Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators.

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.

CSL Behring is committed to provide equal employment opportunity for all.