Quality Assurance Manager Jobs

Summary

The Manager, Quality Assurance provides quality oversight to the Florence East site ensuring continuation of the right to operate in a GxP environment. Develop, implement, and maintain quality assurance systems and activities to ensure compliance with current site SOPs, Corporate Policies, and GxPs. Coordinates activities for staff to resolve quality issues and improve efficiency.

Key Responsibilities

• Initiate, lead and support improvement projects together with operational departments to address, prevent and reduce deviations.
• Accountable for Quality Assurance oversight to ensure the corresponding phase appropriate cGMP compliance according to regulatory expectations.
• Leads and Develops staff in order to realize Environmental Health and Safety (EH&S), Quality and business goals.
• Coordinates corporate policy and gap assessments and ensures delivery to corporate as required.
• Responsible for the effective implementation, monitoring and maintenance of the Pharmaceutical Quality System, ensuring the appropriate authorization of written procedures and documents, the monitoring and control of the manufacturing environment, review/approval of relevant deviations, CAPAs, change controls and other quality system records and plant hygiene.
• Leads team performance through effective key performance indicators, targets and goal settings and provide this data to Site Leadership and the Global Quality organization, as needed.
• Represents Quality Assurance in all Regulatory and Customer Inspections.
• Supports the business development functions, providing appropriate Quality input to prospective customers, including the demonstration of compliance through audit.
• Provides responsive service to internal and external customers.
• Responsible for quality systems on site, including (but not limited to) Customer Complaints, Supplier Quality, Training, Laboratory/Manufacturing Oversight, Validation (Process, Equipment, Computers) Deviation, OOS, Change Control, CAPA Management, Document Management and Audit Management, and including advocating for continuous improvement of these systems.
• Responsible for ensuring that each batch of product has been manufactured and checked in compliance with the local/ regional/ national/ international laws in force and in accordance with requirements of the Marketing Authorization, as required.
• Sets strategy and direction for Quality Assurance to ensure continuous improvements to accomplish compliance in the most efficient way.
• Ensures efficient operations to support commitments to customers regarding product delivery and project deliverables.
• Provides training to Quality Assurance and other department on changes to quality systems.
• Completes resource and human resources planning activities in line with business requirements.
• Coordinates collection of weekly, monthly, and quarterly data as required for site and corporate metric reporting.
• Accountable for the timely disposition of product to allow shipment to customers or internal sites.

Qualifications

• Delegation —the individual delegates work assignments, gives authority to work independently, sets expectations and monitors delegated activities.
• Stress Tolerance — maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization.
• Management Skills —the individual includes staff in planning, decision-making, facilitating and process improvement; makes self available to staff; provides regular performance feedback; and develops subordinates’ skills and encourages growth.
• Technical/Professional Knowledge — having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise.
• Leadership —the individual inspires and motivates others to perform well and accepts feedback from others.
• Decision Making — identifying and understanding issues, problems and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.
• Safety and Security —the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs.

Job Scope

Receives assignments in the form of objectives and figures out how to use resources to meet schedules and goals.

Supervision

Supervisors, and professionals within Quality: motivating, hiring and developing employees, assigns work, provides feedback, mentoring and coaching and taking disciplinary action when required.

Education

Minimum of bachelor’s degree in science/technical or related field.

Experience

At least 7 years of pharmaceutical experience required with at least 3 years in a management position.

Equivalency

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Demonstrates attention to detail, identifies and resolves problems in a timely manner, gathers and analyzes information strategically; able to manage, using reasoning skills and conflict resolution Maintain confidentiality. Motivates and builds a positive team spirit. Maintains a high level of professionalism. Ensures team demonstrates accuracy and thoroughness and looks for ways to improve overall quality of work. Ensures team meets productivity standards by completing work in a timely manner, while striving to increase productivity. Adheres to safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly. Adapts to changes in the work environment. Adheres to attendance guidelines and Good Manufacturing Practices (GMP). Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint. Effective written, interpersonal, and presentation skills. Ability to work on multiple projects simultaneously.

Physical Requirements

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.