Manager, Kit Production in Berlin bei Precision for Medicine
Manager, Kit Production in Berlin bei Precision for Medicine
Precision for Medicine is hiring a Manager, Kit Production to join our team in Berlin.
Position Summary:
The Manager, Kit Production will provide day-to-day management, technical, performance leadership and long-term development of Kit Production at Precision for Medicine Central Laboratory. This role will manage Team Leads and support staff to ensure the successful implementation and execution of new/ongoing Clinical Trials Kit Building, while maintaining adherence to global standard operating procedures and quality control guidelines. Extended work hours may be necessary in order to meet business Demands.
Essential functions of the job include but are not limited to:
Management of Kit Production Team:
Direct oversight of staff involved in the assembly and shipping of consistently high quality visit specific kits to investigator sites
Provides close leadership to meet or exceed required ship dates for kits, and communicate any delays related to production or supplies
Liaise with Inventory Control staff to ensure appropriate supplies are available to support demand
Liaise closely with the Project Management and Study Coordinator to ensure effective preparation and implementation of start-up processes for new protocols
Lead employees through changes impacting daily work, including new system deployment supported by corporate resources Promote and Drive "Right the First Time Quality" and participate/lead cross-functional process improvement activities
Escalates risks/issues in a timely manner
Maintain high level of operational awareness of safety procedures related to kit production
Global Harmonization
Collaborate with leadership teams at Precision for Medicine Central Laboratories to ensure cross-site harmonization in operating procedures, develop and share solutions to issues encountered, and facilitate inter lab Best Practices
Communications & Reporting:
Collection, understanding and Action of Key Performance Indicators/Metrics Measurement and Improvement
Assist clients and collaborators in the design and implementation of new studies by developing logistical plans that optimize quality and efficiency in the areas of Kit Manufacturing
Communicate with clients and collaborators regarding Manufacturing, Inventory and Shipping procedures for Kits
Prepare detailed reports and correspondence regarding ongoing/historical work to clients and collaborators, and department director as required
Resolve complex issues that may arise in the daily operations and assist in resolution of issues that may arise in other areas of our organization. Communicate resolutions in a professional and logical manner.
Employee Development:
Ensure successful onboarding and training of staff members on applicable duties; ensure that all documentation of training is accessible and up to date for all staff members (including oneself). Training will be performed in accordance with global guidelines to ensure cross-site consistency in operator knowledge and skillsets.
Supervise and manage staff in keeping with expressed objectives and corporate culture, and in doing so provide a workplace where ideas are sought and considered, initiative is encouraged, success is rewarded, and employees are treated fairly, with respect and recognition
Conduct regular one-on-one meetings with direct reports, as needed. Share and document information promptly with manager and Human Resources as appropriate
As a member of management, lead through example as well as require adherence to policy, procedure, and professional standards at all times, including interactions of direct reports outside of work and on-line.
Professionally and positively represent the Company by endorsing and supporting company decisions to influence staff "buy in" without conflict
Lead and be actively engaged in Department Stand Up Meetings to ensure management presence and influence is effective and to maintain a high-performance work culture
Provide coaching to supervisors and team leads (as applicable) on effective management of staff. Evaluate leadership and other skills of individual team members and provide appropriate tools and insight for professional development
Miscellaneous:
Attend required in-house management and employee training seminars as scheduled
Carry out other duties/projects as assigned
Edit / Develop SOPs/POPs
Prepare and generate process trainings/demonstrations as required
Initiate documentation of non-conformances/complaints when observed
Maintain training matrix for department
Other duties as assigned
Qualifications:
Minimum Required:
Bachelor's degree or equivalent combination of education and experienc