Teva Pharmaceuticals Quality Group Leader in Baldoyle,
Quality Group Leader
Date: Dec 7, 2018
Location: Baldoyle, IE, CD79
Company: Teva Pharmaceutical Industries Ltd.
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
The Quality Group Leader is responsible for Quality operations at Tosara Pharma including: auditing of all production operations for compliance with current Good Manufacturing Practices, management of Quality Systems within the plant including Deviations, CAPA, Documentation, Change Control, Self-Inspection, Supplier Quality, Labeling etc., providing compliance guidance and regulatory feedback to the facility to insure compliance, preparing and administering the department budget, providing on-going GMP training to the facility, setting the direction for the department and site (in conjunction with Operations management). The Quality Group Leader is responsible for coordinating site regulatory agency inspections. The role provides guidance and direction to Quality staff in their daily oversight of quality assurance processes and accountabilities and ensures Quality personnel perform their duties in compliance with all applicable laws, regulations, GMP, and internal Company policies. The position reports to Head of Quality at the Baldoyle site.
Primary duties and responsibilities of the position are as follows. Other duties may be assigned:
Manage Quality Systems team responsible for Deviations, CAPA, Change Control, Complaints, Artwork, Vendor and Documentation management systems
Management of key quality systems in including Annual Product Quality Review program and self-inspection program
Provide leadership and direction for all Quality activities in a manner which meets or exceeds plant operation and budget goals and integrate the function into the wider plant operation to ensure it meets its commitments to its customers.
Assemble a well-motivated and cohesive team to accomplish long term business objectives and prepare for future growth by identifying, recruiting, and retaining quality staff to support operations growth.
Work in close collaboration with peer managers to coordinate the execution of the production plan and to resolve escalated production issues to ensure operational efficiency in meeting planned production goals.
Establish the expectation and standards, and the supportive environment, to ensure that staff has the capability to meet performance expectations. This includes building staff capability by providing ongoing coaching and mentoring of direct reports, providing timely recognition as well as performance counseling, building and executing development plans, providing career counseling for career progression, and ensuring succession plans are in place.
Maintain accountability for all Quality team performance metrics that support the annual operating plan and production objectives.
Ensure continual improvement of all Quality related documentation (SOPs and On The Job aids) and that they are current, accurate, and clearly define process and role responsibilities.
Encourage process innovation and continuous process improvement in Quality function.
Provide quality and regulatory guidance and leadership to Plant leadership where needed to effectively deal with compliance issues in a timely manner for the benefit of the Plant.
Ensure Plant compliance with HPRA, FDA and other country regulations as appropriate.
Develop a culture of constant site readiness for site inspections.
Consistently lives Our Winning Way and displays behaviors demonstrating Challenge-Connect-Commit , even when it might be unpopular or personally inconvenient to do so. Sets a personal example that reinforces Tosara’s culture, reputation and standards.
Additional job responsibilities:
Prepare and conduct performance appraisals in accordance with Company guidelines.
May lead cross-functional initiatives and projects.
- Bachelor’s Degree or above in Chemistry, Pharmacy or related Science OR equivalent work experiance
Demonstrated success in managing a team in a pharmaceutical production environment and providing leadership for all activities across the site QA operations
Experienced in aligning individuals and teams to business objectives
Experience in managing by metrics
Working knowledge of operational excellence, Lean, Six Sigma
Knowledge and Skills:
Computer literate; proficiency in using Microsoft Office suite
Manufacturing Quality Assurance
In process of validation
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
EOE including disability/veteran