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Operations Site Manager, Drug Product Small Molecules External Manufacturing, Sterile & Packaging Europe

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Job ID: 2518840205

Operations Site Manager, Drug Product Small Molecules External Manufacturing, Sterile & Packaging Europe

Job facts

Job function

Production & Manufacturing

Location

Switzerland, Basle-Town, Basle

Subfunction

Other Production and Manufacturing

Schedule

Full-time

Job type

Regular Employee

Job level

Individual Contributor

Division

Roche Pharmaceuticals

Date

2015/11/16

Get in touch

Contact HR

Lisa Zelmel

Phone

+41 61 687 96 49

Work place:

Basle

External Manufacturing & Quality for Small Molecules manages a global portfolio of third party contractors (CMOs) for drug substance and drug product commercial manufacturing as well as packaging.

The Operation Site Manager is leading the management team which signs responsible for supply and quality performance of the external site and drives the operational activities with a CMO (= Contract Manufacturing Organization). You develop and maintain supply and business relationships with business partners throughout the CMO lifecycle stages while reporting into the Regional Head, Small Molecules External Manufacturing Europe.

Besides managing on-going commercial operations by leading cross-functional team to achieve business, manufacturing, technical and quality objectives and site performance goals the main responsibilities are:


  • Support development and lead/coordinate execution of new artworks changes for the packaging operations at CMO - Small Molecules External. Responsible to initiate artwork changes, influence and drive technical assessments. Act as interface with CMO and Roche artworks groups to ensure smooth implementation of changes
  • Manage/coordinate technical corporate or CMO projects (at CMO level) including change control management
  • Collaborate with Quality on GMP (Good Manufacturing Practice) systems and compliance activities. Participate on operational excellence/ business process project teams to build and utilize robust business processes
  • Identify and communicate risks and issues that impact quality, compliance, project timelines, resource requirements, finances, or business relationship. Manage risk assessment process and lead efforts to execute risk mitigation plans
  • Manage and drive continuous improvement of performance reliability (Right First Time, Supplier Delivery Performance), risk reduction and status of relationship

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You have excellent and demonstrated abilities in building and leading teams, decision-making, communication, teamwork and collaboration. Further on, you communicate effectively in written and spoken English and enjoy to engage with stakeholders at multiple levels and in an international setting.

Further requirements include:


  • University degree in Life Sciences or Engineering with at least 5 years of relevant experience in the pharmaceutical industry
  • Demonstrated operational experience in packaging operations and commercial manufacturing, experience in artworks development/changes incl knowledge of packaging regulatory requirements of secondary packaging development and packaging change qualification/validation requirements
  • Strong quality orientation with extensive knowledge of GMPs, FDA/EMA regulatory guidelines, risk management and validation practices as well as strong ability to lead cross-functional teams in operations projects at all levels of an organization with demonstrated project management skills
  • Demonstrated ability to develop and lead negotiation of supply contracts with minimal guidance with demonstrated skills in financial concepts and cost-benefit analysis with a strong sense of partner relationship dynamics and skills required to influence results
  • English is mandatory, French and/or German is desirable

Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.


Apply online


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