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Quality Assurance Manager - Compliance at US02 Lonza Biologics Inc.

Posted in Science 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Portsmouth, New Hampshire





Job Description:

At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. 

Our vision:

We strive to be the leading supplier using science and technology to improve the quality of life.

Our mission:

We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
 

Do you want to help us as we shape the future of this great organization?

 

Job Description Summary

The Quality Assurance Operations Manager leads a team of QA Compliance Specialists and QA Project Managers responsible for supporting Lonza’s internal and external customers with deviation, CAPA, and change control management; review and revision of customer’s quality agreements; and preparation, review, and approval of Product Quality Report (PQR) sections relating to Quality.  The Manager ensures staff is meeting objectives and deliverables on time and in full, performs key functions such as lot release and co-chair of the Deviation Review Board, CAPA Review Board and Change Control Committee.  This position supports the overflow of tasks as needed to ensure deliverables are met.  The manager assigns the resources and priorities for the team, ensures adequate training, coaches and develops staff, and evaluates performance.  Responsible for actively pursuing opportunities for improvement and promoting a strong culture of quality awareness and GMP compliance.

Key Accountabilities:


  •  Provides general direction and support and acts as a point of escalation for QA staff and customers.

  •  Ensures objectives are met and expectations align with customer Quality Agreements, Lonza SOPs, and regulatory requirements.

  • Identifies and implements improvements to quality processes.

  • Partners with internal customers (MSAT, Manufacturing, Engineering, QC, Validation, and PP&L) to assess and resolve higher risk issues with Change Controls, Deviations, CAPA, and Investigations.

  • Attends and/or co-chairs Change Control Committee, Deviations Review Board and CAPA Board meetings.  Attends Site Quality Council and Lot Disposition meetings.

  • Manage and track Key Performance Indicating Quality Metrics including monthly/quarterly deviation trending reports for senior site management.

  • Performs Lot Release/Disposition activities

  • Provides general direction for department.  Develops team goals, monitors progress and ensures continuous improvement.

  • Conducts regularly scheduled 1 on 1 meetings with staff, and conducts regularly scheduled team meetings to review objectives, provide support and feedback, and assistance resolving issues.

  • May participate in the hiring process, provides performance feedback, coaches, mentors and supports career development.

  • Supports Regulatory and Customer Audits as needed.

  • Adherence to cGMPs is required at all times during the manufacture of APIs.  All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

  • Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.  Must comply with safety policies of the company and site.

  • Responsible for adherence to approved budget

  • Perform other duties as assigned.

Competencies & Behaviors:


  • Agility- Helps others learn from experience to develop themselves.  Adapts thinking and behavior to support change.  Takes personal responsibility for promoting change in his/her area.

  • Business Acumen- Provides feedback to his/her peers and/or team.  Sets and delivers on individual and team objectives that support the company strategy.

  • Collaboration- Generously shares information and knowledge with others across teams and functions.  Actively seeks out and shares different perspectives from a broad network and implements alternative approaches.

  • Customer Focus- Proactively seeks to understand internal/external customer needs. Manages internal and external customer relations professionally and effectively.  Uses systematic approach to ensure customer key metrics are tracked and analyzed for continuous improvement.

  • Driving Results- Establishes and consistently delivers on KPIs and challenging goals for him/herself and team.  Proactively shares credit for successes.

  • Leadership- Supports others in taking responsibility for a safe and sustainable environment.  Takes personal accountability for outcomes resulting from choices and behaviors of self and team.  Creates a positive work environment for his/her team and demonstrates high integrity.

Number of Direct Reports:

  • Six to Ten

Key Skills:


  • Experience managing direct reports and demonstrated ability to mentor and coach to achieve common goals

  • Minimum Advanced years of experience in a GMP environment

  • Biotechnology manufacturing background is preferred

  • Deep knowledge of GMPs and regulations.

  • Demonstrated quality decision making skills

  • experience with TrackWise, SAP, Syncade and Microsoft suite of products is preferred

  • Self-motivated person with excellent written and verbal communication skills to all levels, ability to tolerate challenging workloads and changing priorities.

  • Strong attention to detail is required

 

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

 

Lonza.  The place to Go, Stay and Grow.