Quality Assurance Manager, Responsible Person (RP) and Responsible Person for Import (RPi)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Quality Assurance Manager, Responsible Person (RP) and Responsible Person for Import (RPi)

Location: Basingstoke, UK (hybrid)

Reports into: Associate Director-Quality, UK & Ireland

About Lilly:

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

Role overview:

A fantastic opportunity has arisen as Manager Quality Assurance Representative, Responsible Person and Responsible Person for Import (RPi) at Lilly’s UK Hub Headquarters in Basingstoke.
You will be ensuring that an appropriate Quality Management system is in place and maintained as per Lilly Global Quality Standards and local Medicine’s and Healthcare products Regulatory Agency (MHRA) requirements. Furthermore, you will be actively collaborating with the Marketing Affiliates Quality Assurance team to advice, gain inputs and guidance and involvement on any regional or cross functional project.

These are some of the activities we are looking for you to nail:

You will be Responsible Person (RP) and Responsible Person for Import (RPi) Legal responsibilities

• Perform duties of RP and RPi as documented by the MHRA and maintains the Wholesale Distribution Authorisation.
• Verify that every single batch imported into Great Britain (GB) is EU-QP certified.
• Ensure relevant permits and import/export documentation are obtained for controlled drugs.
• Communicate new policies and legal requirements issued by the local health authority to the Affiliate Lead Team and relevant stakeholders.
• Ensure the appropriate communication to the local health authority of any reportable event related to product quality and product shortages.
• Always keep the Affiliate inspection ready
• Ensures oversight and governance of distribution third parties and maintenance of third-party quality agreements.
• Support the Quality Leader in the resolution of product quality related issues

• Support Global Quality Assurance and Regulatory audits.

Quality Management:

You will be responsible for the operation and continuous improvement of the Product Quality Management System based on Global Quality standards and local regulatory requirements

• Maintenance of the Product Quality SOP system.
• Training of the Affiliate personnel on Product Quality SOPs and processes.
• Responsible for the change management and deviation system and manage all product quality issues (including product complaints) ensuring they are investigated, documented and appropriate CAPA is identified.
• Quality risk management
• Measurement of performance indicators and management review
• Quality oversight and review of distribution activities, (including physician samples) and promotional material that has the potential to impact product quality or patient safety
• Ensure a self-inspection program is in place and inspections are carried out at appropriate regular intervals.
• Recall coordinator
• Ensure appropriate external third - party oversight by performing assessments, monitoring performance and quality governance in compliance with Global Quality Standards.
• Support new product launches.

You will come to us with:

We are looking for you to have experience working in a multinational pharmaceutical company with a focus on pharmaceutical product distribution.

• Science degree or equivalent, must be eligible to be a Responsible Person (RP) and Responsible Person for Import (RPi)
• At least a few years’ experience in the application of Good Distribution Practice (GDP) regulations.
• Knowledge of the key requisites of products traded under the WDA (H) and Home Office Controlled Drugs license
• Knowledge of the role of the MHRA & HPRA in the licensing of medicines’,
• Knowledge of relevant UK, IE & EU legislation
• Excellent communication skills: Oral and written
• Influence: Strong interpersonal and negotiation skills
• High attention to detail and accuracy

Additionalinformation:

• Pharmaceutical manufacturing experience would be advantageous
• Local travel (UK and Ireland) up to 8 times a year

Bring your true self to work:

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

Sound like you? Apply now to be a part of our high performing and diverse team. In return, we’ll give you the opportunity to thrive in the role while bringing your authentic self to work.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.