SENIOR MANAGER, QA
BRIEF COMPANY PROFILE
Our client is a global, market-leading science company that develops, manufactures and sells scientific instruments, equipment, software and services, and reagents and consumables to a variety of scientific research fields including pharmaceuticals, biotechnology, academics, environmental and industrial research as well as clinical research.
The company prides itself in serving a diverse customer base making the world healthier, cleaner, and safer on all ends.
Their products are Class I and II medical devices or IVD products.
The Senior Manager, Quality Assurance, will lead the Quality Team of our clients manufacturing site in Greater Copenhagen, Denmark and hence Quality Representative of the site while taking a seat on the site leadership team. The role will assume responsibility for three key functional areas: The Quality Systems Department (QMS, doc’s, vigilance etc.), the Technical Quality Department (validation, calibration, metrology etc.) and the Operations Quality Department (QC lac, process control etc.).
Heading up a team of 35+ QA/QC professionals including 5-7 direct reports, the role will be globally responsible for the QA and QC function at the manufacturing site in Roskilde - hereunder setting the overall quality strategy for the site that supports growth and compliance readiness. The role is accountable for improving product and process quality, compliance and improvements in quality systems, managing customer expectations and creating efficiencies within the quality group to meet business expectations.
The ideal candidate for this position has proven experience in quality management from a medical device or IVD setting. Further, successful team leadership and people management experience is a must.
Senior Manager, QA
Global Director, QA
Responsibilities & Tasks:
Setting the overall quality strategy for the manufacturing site, supporting growth and compliance readiness.
Providing leadership to the Quality Control lab, factory quality, and the Quality Assurance teams.
Carrying out personnel management responsibilities, including: Interviewing, hiring, developing and training employees, planning, assigning, and directing work, appraising performance of employees, addressing issues and coaching good behavior.
Moving the organization from Quality Control to Quality Assurance through quality improvement projects and by setting site-wide QA/QC priorities and key objectives.
Overseeing the Quality Management System, meeting international quality systems requirements (ISO 13485, IVDD, CFR 820).
Supporting the team to ensure that the QMS is understood, implemented, and maintained.
Assuring that management reviews are conducted and reflect the status of QS effectiveness.
Initiating cross-functional collaborations across business functions securing the application of quality tools (Lean, Six Sigma, TQM principles), business improvement methods, and statistical methods (e.g. design of experiments).
Key success criteria:
Successfully developing and executing the site quality strategy, creating efficiencies to meet business expectations.
Demonstrating strong leadership and personnel management skills to further both employees and the organization in their mission.
Managing the quality organization in adherence with the organization’s policies and applicable laws/regulations.
Bachelor’s Degree in Engineering or Science.
English – fluent (verbally and written).
Ideal experience and competencies:
10+ years of Quality Management experience in a medical device or IVD company setting.
Broad experience with ISO 9001 and ISO 13285 standards.
Well-versed in managing CAPA system and SPC programs.
Experience using problem-solving techniques such as PPI, 8D, DMAIC, PPS.
Experience with FMEA and other risk management tools.
Proven leadership experience as well as strong communication and personnel management skills.
MSDAP (Medical Device Single Audit Program) experience is an advantage.
Lean or Six Sigma improvement systems experience is preferred.
Experience in high volume plastics/molding industry is desirable but not a must.
Makes sure employees/co-workers have a clear understanding of the direction of the tasks; takes action; organizes resources and direct others toward successful execution of the tasks; drives projects forward to reach pivotal objectives; makes things happen and follows through. Can manage multiple projects and teams simultaneously.
Plans a focused course of action for himself/herself and others, ensures an appropriate assignment of tasks for employees, schedules an optimal use of the available resources. Sets both formal and objective goals.
Results and goal orientation
Establishes visible and achievable goals across the organization. Focus on action, activities and results. Is able to continue working at a specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed.
Actively trying to improve the skills and talent of the employees by giving positive and constructive feedback. Provides training and tasks with a view to challenging their skills and encourage development.
Delegates responsibility to the relevant employees and allows them room for manoeuvre to explore own initiatives, empowers people in order for them to carry out tasks efficiently.
Praise and recognition
Notices good performance, acknowledges efforts and results, highlights the results achieved.
Creating career paths
Attracts and recruits well-qualified employees, spends time and energy on developing employees with great potential.
Is concerned with reaching and maintaining quality while balancing business objectives; sets high standards for performance and execution – for one self and for others.
Identifies issues and take appropriate actions according to corporate guidelines and policies.
Is able to establish and maintain relations with people at all levels internally as well as externally and make people feel at ease. Achieves agreement by dealing with disagreements and potential conflicts with diplomatic skills. Develops and maintains networks.