Advisor - Quality Assurance

Provides Quality Leadership and GMP Compliance Guidance for global R&D functions, Project teams and thereby supports new global product development, registrations, licensing, technical transfers and product launches.

This position develops strong partnerships and positively influences the various R&D functions, Project teams and CMO s to provide guidance and support on overall quality strategy and to meet requirements of both Elanco and applicable regulatory authorities.

Proactively seeks solutions to lead and drive quality compliance through implementation, monitoring and improvement of Elanco Quality Systems, training and compliance tools, with expert focus on Technical Development activities.

Functions, Duties, Tasks
1. 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.
2. Drives Quality Excellence in Global R&D and QA teams with expert focus on cGMP and non-regulated oversight. Develops and executes components of Quality plan, self-inspection and supports Quality metrics together with business functions.
3. 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 non-regulated, cGMP and proficient in other regulated areas such as Quality Management Systems.
4. Build strong relationships with internal and external business partners in R&D, TS/MS, CMOs/TPOs and Quality. Interacts with customers, regulators and outside stakeholders.
5. 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.
6. 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.
7. 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.
8. Provides and develops quality and compliance training for R&D teams.
9. 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).
10. 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. Supports R&D in new third party (CMO, CRO) or supplier selection and approval qualifications (audits).
11. Responsible for maintenance (initiation, review, renewal etc.) of Quality Agreements with third parties for development activities where required.
12. Responsible for releasing investigation material (drug substance, drug product etc.) and other development materials as per Elanco Quality requirements. Trains others to do so as delegates.
13. Comply with all company local and global policies including all Elanco Global Quality Standards, Elanco Ethics and Compliance and HSE policies.
14. 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: Ph. D. in Life Sciences or similar degree and/or relevant equivalent experience in Technical Area (Pharmacy, Biology, Biotechnology, Chemistry)
Experience:
Greater than 5 years experience in Quality Assurance, Quality Control or related technical field (Pharmaceutical Development, Manufacturing, Chemical Engineering etc.)
Experience Vaccine/animal health, Biotherapeutic (large molecule) development experience, with R&D-related Quality Assurance
Strong background in pharmaceutical manufacturing and/or R&D
Excellent English communication skills, verbal and written
Expert knowledge in several of the following: GMP, compliance in one or more global regulatory requirements (EMA, FDA/CVM, MHRA/VMD,) 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 problems, collect and review information & data, draw valid conclusions

Additional Preferences:
Fluent in English
Skilled in risk-assessment methodologies
Auditing experience
Advanced Certifications and degrees, desired

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