Sr. Quality Associate-Quality Assurance (m/f/d)

At Elanco (NYSE: ELAN) – it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals’ lives better makes life better – join our team today!

Provides Quality Leadership and Support 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, with expert focus on Small and Large Molecule Development including Biotherapeutics.

Functions, Duties, Tasks:

• Provides Quality Leadership to R&D functions and project teams at a global level.
• Drives Quality Excellence in global R&D and QA teams with focus on cGMP, oversight. Supports components of site and global Q plans and supports Q metrics together with R&D functions.
• Supports local interactions with Health Authorities regarding R&D GMP activities e.g. hosting local HA inspections.
• Collaborate and evaluate scientific, business and quality aspects of global projects and procedures to positively influence business partners and outcome.
• 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 technical experience and scientific knowledge to find customer oriented and fit-for-purpose solutions for projects and process challenges around quality issues.
• Provides guidance to and supports R&D 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.
• Works with teams in establishing, maintaining and improving the quality system in accordance with the ELANCO Quality Manual with particular focus on the procedures and SOP system in R&D Technical Development.
• Provides and develops quality and compliance training to R&D teams.
• Support local quality 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).
• 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.
• 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

Minimum Qualification (education, experience and/or training, required certifications):

Education: Degree in Life Sciences and relevant experience in Technical Area

(Chemical Engineering, Pharmacy, Biology, Biotechnology, Chemistry).

Experience:

• 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

• Experience with Quality Systems, processes and training

• Knowledge of PC tools including all MS Office applications.

• 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

• Ability to work effectively with teams.

• Excellent communication

• Fluent in German

• Fluent in English

Additional Preferences:

• Ability to become QP/IVP/IMP certification

• Skilled in risk-assessment methodologies

• Auditing experience

Other Information:

• Expected travel: up to 10-20%

• Functional leadership role to external and internal resources and consultants

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status