QA manager development (design control in IVD)
QA manager development (design control in IVD)
NA NA Mechelen Belgium
The company is an innovative commercial stage molecular diagnostics(MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. The Company’s proprietary platform is a fully automated, real time system which offers accurate, highly-reliable molecular information from any biological sample in virtually any setting. It addresses the growing demand for personalized medicine by allowing fast and effective treatment selection and treatment progress monitoring.
The company is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest and largest growing segments of the US$5 billion MDx market which is expected to grow to approximately US$8 billion in 2018.
The key mission of the QA Manager Development is:
to develop a 'functional powerhouse' with highly capable resources, and
to operate as the QA counterpart for process owners to establish efficient and effective product development processes.
The QA Manager Development also provides expert input to programs and coaching to the employees and teams.
The QA Manager Development’s primary role is talent, competence and resource management. He/she is an expert in his/her respective discipline.
In this way, the QA Manager Development will make sure that his/her function performs at the best of its ability by having talented and trained resources and effective and efficient processes in place.
The Quality Assurance (QA) Development team is responsible for all Quality Assurance activities related to the development and life cycle of Biocartis products. This includes QA support to product development or life cycle projects governed by the Product and Partner Business Areas as well as non-business area-related QA support to the Product Development functional area.
The QA Manager Development is accountable
For the resource and talent management as well as operational excellence of the QA Development team;
To verify that QMS procedures and work instructions for product development, including but not limited to Design Control and Software development and validation are in accordance with applicable regulation; this also includes the financial and operational accountability for any related objective with regard to Quality;
To verify that QMS procedures and work instructions for the Development Laboratory Operations (facilities, utilities, equipment, software applications, generic methods) meets regulatory requirements and that they are adequately applied; this also includes the financial and operational accountability for any related objective with regard to Quality.
In this respect, the role includes the following responsibilities
To ensure competence and capacity of QA Development personnel to support all Product Development and Laboratory Operations activities. This includes amongst other establishing a resource and competence plan in line with the company strategy, product roadmap, company objectives and budget;
Liaising with project and Quality lead to deliver competence and capacity according to business area demand and budget;
To maintain optimized and balanced availability of QA Development resources versus demand within and across non- business area - related QA development activities;
Overseeing overall QA Development team allocation;
To coach, evaluate and develop the QA Development personnel;
To lead all QA Development support to Product Development Processes or Laboratory operations, while continuously striving for performance improvement and effectiveness;
In consultation with the Quality leadership team, cascading company objectives within the respective team;
To provide Quality expertise in continuous improvement of the the Product Development processes and Laboratory Operations;
To ensure inspection readiness within defined accountabilities and ensure availability of appropriate site representation during internal audits and external inspections;
To lead or participate in internal and supplier audit activities;
Reporting and/or escalating to the appropriate governance body.
Requested competences and skills:
Master or bachelor degree in a technical or scientific orientation is required or similar through experience;
Minimum 7 years of experience in medical device or diagnostics industry of which minimum 5 years in Quality Assurance;
Experience with product development;
Deep understanding and knowledge of applicable QMS procedures and work instructions, including but not limited to design control, software development and validation, process development and validation, quality control, supplier control, equipment qualification, post market surveillance, product release and event management processes;
Understanding of the technical aspects of Biocartis products;
Supporting & facilitating change: enables and shapes change, helps others to understand the need for change and adapt to it;
Maintains self-control, direction and effectiveness in high pressure situations;
Maintains team’s effectiveness, quality and morale during difficult times;
Strategic thinking: translates Biocartis vision and strategy into SMART plans for team & programs;
Coaching & development: designs, implements and encourages a feedback & coaching culture, creates an environment where leadership and talent development is a top priority;
Analytical thinking: makes evidence-based judgements that guide organizational decisions;
Sets direction to the team: is able to motivate, guide and direct staff members in reaching their business goals;
Monitors and/or evaluates performance, provides balanced feedback and ensures support to develop the required competencies;
Knowledge of and familiarity with following guidelines and regulations:
ISO 13845, 21 CFR part 820, MDSAP and IVDR;
ISO 14971, ISO 62366, ISO 62304, GAMP;
Experienced with design control in an IVDR setting.