Job Description
Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
To support our Clinical Research Team, we are looking for a Clinical Supplies Complaint Coordinator (m/f/d) in full-time and permanent capacity. This is a Global Remote Position.
The position performs disposition assessment of reported clinical supply temperature excursions that occur at clinical sites globally. The position interacts directly with clinical sites to obtain complete temperature excursion data and provides the disposition of the impacted clinical supplies to the sites.
The role is critical in the clinical supplies chain; timely evaluation, stability assessment, and proving disposition of the impacted clinical supplies to sites are essential in maintaining availability of clinical supplies at sites without disruption.
The role works closely with Global Clinical Supplies, the Global GCD Clinical Supplies Lead SME, and several roles in Quality and Continuous Improvement (QCI).
In collaboration with QCI, the role may trigger GCP clinical supplies investigations for Country Operations to complete.
Primary Responsibilities:
- GCP clinical supplies complaint intake, evaluation, product impact assessment, and disposition of clinical finished good supplies impacted by temperature excursion.
- Manage GCP clinical supplies complaints in a centralized system and ensure complete documentation.
- Coordinate and/or support the preparation of procedures, processes, and quality improvement activities.
- Initiate GCP clinical supplies investigations for GCTO Country Ops to complete.
- Provide support for metrics compilation that are presented at various governance councils.
Your Profile:
- Bachelor’s degree, technical emphasis in an appropriate scientific or engineering field preferred.
- 2 years of post-degree experience in the Pharmaceutical or equivalent industry – in Good Clinical Practices (GCP) or Good Manufacturing Practice (GMP) related field, including Technical, Engineering, Quality or Operations.
- Effectiveness and creativity in approaching and solving technical problems.
- In-depth working knowledge of clinical supplies complaints or GCP related regulatory requirements for supplies as they apply to the pharmaceutical field or a related area.
- Basic understanding of MS Office applications.
- Evidence of leadership skills coupled with highly developed oral and written communication skills, effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.
- Demonstrated teamwork skills and the ability to work independently.
- Attention to detail, flexibility, and an awareness of production and quality control problems.
- Ability to adapt in a changing working environment.
Preferred Experience and Skills:
- Familiarity with complaints and/or batch disposition (release) activities is a strongly preferred skill necessary for success in this position.
- Previous experience in quality control, quality assurance, auditing, or regulatory affairs.
- Ability to independently manage multiple priorities and projects.
- Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.
- Demonstrated analytical and problem-solving skills, experience in Lean Six Sigma, and Project Management.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact on our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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