Job Overview

Accountable for driving the Quality Assurance delivery program within assigned region. Oversee support of customer / functional accounts, audit and inspection programs, business analytics, and QA quality management systems.

Responsible for ensuring teams within the region have clear focus and understanding of QA strategy and that services are executed and delivered to the highest standards and within budget.

Essential Functions

Oversee direction of Quality Assurance Program, as assigned

Ensure quality assurance organization and operating procedures are in place to support assigned program(s) of work

Oversee QA delivery by ensuring staff have a clear focus and understanding of QA strategy and that services are executed and delivered with effective and efficient processes to follow

Ensure there is regular assessment and oversight of performance and that services are executed to the highest standards of compliance with regulations, standard operating procedures and principles of process management

Ensure there is a continuous improvement program to optimise processes

Ensure the program of work is delivered within budget, time frame and resourcing constraints

Identify risks to delivery of the program of work and manage the mitigations

Identify opportunities for improvements, efficiencies, and elimination of redundant activities, ensuring the program of work continues to represent excellent value to te business in return on investment

Support the Global Head of QA and collaborate with peers in collective responsibility for the delivery of all QA services

Undertake other essential and critical operational duties in line with department need, e.g, Host customer audits and / or regulatory inspections, and oversight preparations of prepare corrective action plans and effectiveness checks

Participate in or lead teams for special projects as assigned. Teams may be cross functional

Ensure industry standards training of department staff for regulatory inspections

Supervise consultation, guidance, tracking, and metrics system

Interface with senior management to discuss quality and compliance issues

Interface with business development and operations to identify business opportunities

Recommend staff management actions in accordance with organization’s policies and applicable laws.

Performs other duties as needed.

Qualifications

Bachelor's Degree Req

15 years experience in pharmaceutical, technical, quality assurance, or related area, including 6 years of management experience.

Equivalent combination of education, training and experience.

Knowledge of word-processing, spreadsheet, and database applications.

Extensive knowledge of pharmaceutical research and development processes and regulatory environments.

Considerable knowledge of quality assurance processes and procedures.

Strong interpersonal skills.

Excellent problem solving, risk analysis and negotiation skills.

Effective organization, communication, and team orientation skills.

Ability to influence and guide others.

Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Location : EMEA