Responsibilities :

• Assure the robust selection and on-boarding of CMO’s / Suppliers that perform testing for Elanco are in compliance with regulatory cGMP requirements and the Elanco Quality Manual / Directives
• Manage and support the resolution of issues at CMOs / Suppliers, escalate issues appropriately and timely drive corresponding continuous improvement initiatives.
• Support and guide internal functions within Elanco and external partners ( interpretation of regulations / standards, inspection readiness, etc.)
• Manage contract laboratories that perform testing of commercial products
• Review and approve OOS, OOT Investigations, and deviations related to QC activities and perform assessments and visits of contract manufacturers and laboratories.
• Assist with preparation and review of submission documents
• Provide support for new product launches / acquisitions to ensure compliant systems and procedures are in place to manage new products
• Leverage subject matter expertise in the review and approval of technical documents supporting the validated state of commercial product, including laboratory validation reports, technical documents, and stability reports
• Partner with QC SMEs in the EEM network for continuous processes and procedures improvements and alignment with the respective Quality Control practices.
• Collaborate and / or partner with Global QC network, QA / QC and TS / MS SMEs across organization in projects and routine to support multi-countries marketed products.
• Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and / or training
• Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

What You Need to Succeed : (basic qualifications) :

• Degree in chemistry, biochemistry, engineering, pharmacy, biology
• Minimum 8 years demonstrated Quality / technical leadership experience in the pharmaceutical industry, specifically supporting method transfers, method validation, method optimization, compliance remediation activity.

API chemistry experience highly preferred

• Experience performing oversight and audits of laboratories
• Demonstrated cGxP experience, specifically leading complex investigations; deviation / CAPA management; change leadership and risk management
• Strong knowledge of mathematics, data analysis, and statistical methods and current working knowledge, including audit / inspections, of the regulatory environment FDA; EU, etc.
• Demonstrated understanding of scientific and technical data, problem solving, quality risk management, project management and decision-making skills
• Excellent communication and listening skills, with strong observational, analytical, and problem-solving skills.

What will give you a competitive edge (preferred qualifications) :

• Master’s degree preferred in chemistry, biochemistry or chemical engineering
• Continuous Improvement (Operational Excellence / Lean) leadership can comfortably quantify & articulate the impact of projects and their impact to an organization

Expected Travel : Up to 20%

Don’t meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification.

At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply.

You may be the right candidate for this role or other roles!

Elanco Benefits and Perks

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include :

• Relocation packages
• Two-week shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 10-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching
• Dependent and childcare support

Last updated : 2024-06-25