SENIOR MANAGER, QA OPERATIONS
BRIEF COMPANY PROFILE
Our client is a global leading provider of technologically advanced acute care solutions that simplify and automate all phases of acute care testing. The company’s advanced solutions and products help healthcare professionals get fast and accurate information on the most critical parameters in acute care testing. This is the foundation for making immediate and well-informed decisions on the treatment of critically ill patients in clinical settings such as emergency care, intensive care, anesthesiology, cardiac surgery, neonatal care and wound care.
The company is located in Greater Copenhagen.
The Senior Manager, QA Operations position will be leading a team of 5 QA specialists (with an additional 5 QA Specialists approved/budgeted) focusing on vital decisions regarding quality assurance in Operations, Supply Chain and Procurement. The problem-solving and decisions taken in the QA Operations area have a severe impact on customer quality and on production efficiency. The Senior Manager makes daily decisions that have a high impact on the business results and requires the ability to navigate efficiently with stakeholders particularly from Operations in relation to quality actions and quality decisions. The job requires excellent proven leadership or project leadership skills and the ability to make quick decisions while holding a holistic view on quality and delivery.
The position as Senior Manager, QA Operations is located in Greater Copenhagen, and reports to the Director of QA Engineering and Operations – in a department with more than 25 employees divided into 5 teams, of which QA Operations is one.
Senior Manager, QA Operations
Director of QA Engineering and Operations
Responsibilities & Tasks:
Leading role in QA Operations platform:
Leading a team of specialists responsible for the Quality Assurance in daily operation tasks such as NCR handling, engineering change orders/change control, process validation, production risk management, problem-solving and similar.
Evaluating non-conformities and approve disposition decisions.
Participating in production change projects as QA manager.
Tracking timely CAPA handling in Operations to ensure that problems are solved.
Ensuring the provision of guidance for QMS- and regulatory compliance in an FDA regulated and ISO compliant environment.
Continuously allocating resources and planning within the department and with relevant external partners hence ensuring effective and timely handling of deliveries as committed.
Enforce corporate policies and procedures.
Collaborating closely with managers and stakeholders in Operations, Design Transfer/Design Control and CAPA team to ensure timely and compliant product deliveries.
Leading the QA Operations team meetings.
Participating in R&D project development projectsrepresenting QA Operations.
Ensuring training and development of associates in QA Operations.
Participating in quality training activities.
Lean process management:
Employing a lean process view to constantly improve quality processes to become more efficient, lean and in compliance with regulations.
Updating knowledge level:
Keeping updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD while ensuring the updating of relevant parts of the QA Operations.
Assessing overall QA Operations risk by deploying risk management tools and contributing to the risk management evaluations.
Ensuring allocation of resources to internal and external audits.
Key success criteria:
Ensuring close collaboration between QA Operations and Operations – hereunder the various sites in DK, USA and Poland.
Successfully leading and executing on key QA projects – hereunder transfer of production to China.
Successfully facilitating and leading a high- performance culture focused on adding value in alignment with the business.
Contributing to fostering a DBS culture to build future QA muscle and ensuring that DBS is leading the way to sharpening focus on reaching the vison.
The ideal candidate holds a M.Sc. or B.Sc. degree in
engineering, pharmacy or like. However, if the candidate
has a good technical aptitude other relevant education is
English – fluent (verbally and written).
Ideal experience and competencies:
Preferably 5-10 years of experience within QA Operations or Operations combined with broader QA experience – preferably from an IVD or Medical Device production environment.
Broad experience with line management or project management leading complex teams.
Well-versed in Production Risk Management.
Demonstrated ability to lead optimization of qualityprocesses in Operations to support business drivers (on-time delivery, product quality, reduce rework/waste).
Proven track-record with problem solving and continuous improvements.
In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets.
Good working knowledge of IT tools and specifically quality management systems.
Profound experience with MS Office.
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.
Is proactive and able to inspire others and take own initiatives without hesitation. Actively leads, takes initiative and starts up actions.
Is naturally self-confident, reliable, trustworthy and able to take severe decisions, while withstanding adverse conditions. Encourages the achievement of set goals by promoting a sense of purpose and demonstrates strong drive, stamina, natural authority, and responsibility, while prompting a strong wish to support and lead the team to success.
Is prepared to make timely and rapid decisions – also when information is limited, accepts clear action plans.
Empathetic team player
Displays a high degree of empathy and employs this trait to collaborate well with others with a view to obtain the team's objectives; shares information; supports others.
Makes rational, realistic and sound decisions based on the involvement of available facts and possibilities. Is able to make the right decisions.
Utilizes critical thinking. Maintains overview in situations that requires quick decisions, including a holistic view to quality and delivery. Intelligently divides problems into relevant parts, sensitively integrates analytical output into a given context and differentiates between key areas and irrelevant and less important areas. Applies a logical mind- set and makes sensible decisions based on available information and a strong business understanding.
Actively focusing on improving 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.
Takes well thought-through decisions in highly complex environments.
Attentive to detail; works systematically and is highly organized and methodical; able to simultaneously handle and prioritize many tasks with short deadlines, while displaying perseverance and consistency towards commenced responsibilities, tasks and projects.
Champion the philosophy of continuous improvement with a high degree of integrity fostering transparency, reliability, and trustworthiness – personally and professionally.