Director Operational QA

hace 3 semanas

Barcelona, España Thermo Fisher Scientific A tiempo completo

**Director Operational QA**
- _The role is available in most EMEA locations_

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our

PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

**Position Overview**:
Provides strategic direction, leadership and management of QA department(s). Provides oversight to quality management process, systems and tools, identifies treds, evaluates best practice and drives improvement initiatives. Assists business development and senior management in securing new business. Develops effective solutions, using proven problem solving techniques, to address nonconformance issues. Supports overall financial goals for department.

**Main duties and Responsibilities include**:

- Develops and executes compliance strategies and establishes quality and compliance standards within and across GQC business units
- Analyzes compliance/quality matrix data, notifies senior management of critical compliance nonconformance
- Takes leadership role with peers in operational units to proactively identify issues relating to quality and/or data integrity, determines root cause of nonconformance, and develops effective problem solution strategies
- Provide strategic and tactical direction to staff for assigned department(s) in execution of departmental objectives
- Hires, develops, and mentors staff to expand organizations capability and ensure effective management of QA staff
- Manages contracts to ensure contractual obligations and business requirements are met
- Serves as a senior advisor to peers, teams, and clients on the interpretation and implementation of current GxP and computer validation trends and requirements
- Assesses impact of client and regulatory observations of data integrity and overall quality management and provides recommendation for corrective action to the respective teams
- Represents QA in business development activities to obtain additional contracts by writing and reviewing proposals, making presentations to potential clients and representing the department at appropriate professional meetings and conferences
- Builds client relationships and provides strategic guidance on quality business initiatives. Provides regulatory support for clients as needed for addressing regulatory concerns such as validation issues and agency questions as needed
- Maintains leadership role through active participation in leadership team meetings, presentations to site staff on compliance and quality issues
- Trends applicable quality metrics. Identifies and leads quality and business process improvement issues
- Manages delegated tasks and responsibility as requested by senior leadership. Represents QA at client audits and regulatory authority inspections
- Maintains expertise with international regulatory requirements by attending external training programs, maintaining current reference library and attending regulatory authority sponsored public conferences
- Establishes policies appropriate for the function. Interprets and recommends modifications to company-wide policies and practices. Develops and is responsible for budgets, schedules, and performance standards.

**Qualifications. Education and Experience**:

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 12+ years).
- 5+ years of management responsibility
- Strong leadership skills
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role._

**Knowledge, Skills and Abilities**:

- Advanced leadership skills and business acumen
- Advanced knowledge of financial management and budgeting
- Strong organizational agility with ability to successfully operate in a matrix or team environment
- Ability to successfully hande multiple responsibilities, priorities and tasks
- Excellent training/mentoring experience of junior staff on a variety of processes
- Exceptional oral and written communication skills
- Excellent interpersonal skills
- Well developed problem solving, root cause analysis, risk assessment and impact analysis abilities
- Thorough knowledge

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