Founded in 1954, Elanco is a global research-based company that develops and delivers products and services to enhance animal health and production. Our products, services and global partnerships support our vision of enough food and companionship enriching life. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 6,500 employees in more than 70 countries.
Position Description: Provides Quality Leadership for global R&D functions and project teams and thereby supports new global product development, registrations, licensing, technical transfers and product launches. Develops strong partnerships and positively influences the various R&D functions and project teams to provide guidance and support on overall quality strategy and to meet requirements of both Elanco and applicable regulatory authorities. Proactively seeks solutions to drive quality compliance through implementation, monitoring and improvement of Elanco Quality Systems, trainings and compliance tools.
Functions, Duties, Tasks:
Provides Quality Leadership to R&D functions and project teams at a global level. Assures adequately trained and knowledgeable quality resources are available to support R&D for projects assigned.
Drives Quality Excellence in global R&D and QA teams with focus on cGMP, GCP, GLP and GRP oversight. Develops and executes components of site and global Q plans and develops Q metrics together with R&D functions in Basel and US.
Understands the local, regional and global requirements and meets regulatory compliance.
Represents R&D QA at Manufacturability Reviews to ensure smooth technical transfers from development to manufacturing (TS/MS Commercialization).
Independently evaluates scientific, business and quality aspects of global projects and procedures to positively influence business partners and outcome. Recognized as expert in quality compliance for GRP, GCP, GLP and cGMP.
Builds strong relationships with internal and external business partners in R&D, TS/MS, CMOs/TPOs and Quality. Interacts with customers, regulators and outside stakeholders.
Applies depth and/or breadth of technical experience and scientific knowledge to find customer-oriented and fit-for-purpose solutions for projects and process challenges around quality issues.
Sets overall quality and compliance strategy for R&D projects in consultation with the project teams. Provides guidance to and supports the project teams throughout the entire development program.
Scientific and compliance review and approval of GxP documentation for manufacturing and registration including but not limited to pre-clinical, clinical and CMC protocols and reports.
Responsible for establishing, maintaining and improving the quality system in accordance with the Elanco Quality Manual with particular focus on the R&D procedures.
Provides and develops quality and compliance training to R&D teams.
Leads large scale projects/initiatives that have high impact to the Quality and/or R&D organization.
Responsible for compliance audits and QA oversight at the local site, for global R&D and for GxP qualification and oversight activities at third parties. Issues self-inspections reports and reviews & approves responses and corrective & preventive actions (CAPAs).
Coordinates preparation activities for regulatory authority inspections with the business partners, site QA and Global Quality Compliance &Auditing (EGQCA) to ensure inspection readiness at site. Hosts local HA inspections as required and thereby represents Elanco as well as manages responses and commitments.
Supports new product acquisition and due diligence as needed. Manages new third party (CMO, CRO) or supplier selection and approval qualifications (audits).
Responsible for maintenance (initiation, review, renewal etc.) of Quality Agreements with third parties for development activities where required.
Qualified to release investigational material (drug substance, drug product etc.) and other development material as per Elanco Quality requirements. Trains others to do so as delegates.
Monitors and tracks strategic initiatives, projects and prepares status reports. Helps drive adequate management attention and decisions by communication and escalation processes.
Management of trending, change control, deviations, CAPAs and out of specifications.
Comply with all company local and global policies including all Elanco Global Quality Standards, Red Book and HSE policies.
Perform any other duties or serve in such other capacity as may be determined by Company Management.
Education: Ph. D. in Life Sciences or similar degree and relevant experience in Technical Area (Chemical Engineering, Pharmacy, Biology, Biotechnology, Chemistry)
7+ years experience in Quality Assurance, Quality Control or related technical field (Pharmaceutical Development, Manufacturing, Chemical Engineering etc.)
Strong background in pharmaceutical manufacturing and/or R&D
Expert knowledge in the following: GCP, GLP and GMP compliance, in one or more global regulatory requirements (EMA, FDA/CVM, USDA, MHRA/VMD, CFIA) as well as in regulatory submissions
Experience with Quality Systems, processes and training
Knowledge of PC tools including all MS Office applications and Internet
Ability to set priorities and manage multiple tasks
Effective interpersonal and team building skills, ability to influence without authority to drive favorable outcomes while maintaining positive working relationships
Ability to interpret regulations & policies and to make recommendations
Solid project leadership skills, ability to work effectively with teams.
Strong analytical skills: can define problem, collect and review information & data, draw valid conclusions
Excellent communication skills, verbal and written
* Fluent in English * Skilled in risk-assessment methodologies * Auditing experience * Experience in vaccines, enzymes, nutritionals of benefit
* Location: Basel, Switzerland * Travel requirements: up to 10% * Reports to: Regional R&D Quality Leader EMEA & AsiaPac