Mundipharma is a global (ex-US) network of independent associated companies that research, develop and manufacture innovative pharmaceutical medicines and consumer healthcare products. We are an agile and fast-paced company seeking to increase access to health care through programmes and effective partnerships.
We are forward-looking and dedicated to bringing innovative treatments to many of the world's most challenging conditions and diseases including: Pain Management & Supportive Care, Consumer Health, Anti-Infectives, Biosimilars, CNS, Diabetes, Oncology, Ophthalmology, Respiratory and transplantation immunity.
We make a difference to patient lives by delivering value to healthcare professionals in 120+ countries across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.
Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great place to work.Job Description
Help ensure the quality compliance of Mundipharma's Independent Associated Company (IAC) network by leading the Quality Operations Team to:
- On behalf of Mundipharma's Independent Associated Company (IAC) network; register various Quality and Security incidents and route these for completion.
- Monitor compliance of the Quality function with internal procedures.
- Support the administrative needs of the Quality function
- Manages the Quality Compliance team utilising effective time and workload management skills to meet defined milestones and deadlines.
- Supports and develops the individuals within the Quality Compliance team by ensuring they have the appropriate skills, knowledge, and expertise in order to meet current and future organisational requirements.
- Assists with logging and responding to product complaints and distribution temperature excursion incidents by liaising with other departments and IACs.
- Undertakes quality data trend analysis by employing data analytics and compiling reports for management quality reviews and product quality reviews
- Presents quality data trend analysis at management review forums.
- Champions the product complaints process by maintaining, tracking, and improving the associated documentation and systems to ensure:- effective processes and procedures are in place in line with Mundipharma Quality Framework and policies, cGMP and local regulatory requirements- continuous improvement opportunities are identified and implemented to maintain and advance Mundipharma's compliance posture and effective and efficient operations.
- Supports inspections and QA audits by hosting or presenting, coordinating logistics, and assisting with the facilitation and coordination of responses to maintain and advance Mundipharma's compliance posture and effective and efficient operations.
- Supports QA audits by occasional co-auditing to maintain and advance Mundipharma's compliance posture and effective and efficient operations.
- Aligned working experience
- Scientific degree in Pharmacy, Chemistry, Biology, Engineering or similar (preferred)
- Aligned working experience
- Certification in Quality Systems Management or similar (preferred)
- Experience in a quality related role within the Pharmaceutical Industry or related technical industry
- Extensive practical experience (2+ years) in Quality Management Systems within the Pharmaceutical Industry and/or Medical Devices (preferred)
- Team management experience (preferred)
Knowledge and Skills
- Excellent communication skills (including public presentation and technical report writing skills) and ability to communicate and interact at all levels of the business and externally;
- Ability to motivate and support the development of team to achieve the goals of the department and the overall business.