Director, QA Operations
Director, QA Operations
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Job Description
We are excited to invite applications for the Quality Director position in our Eyecare business at AbbVie Westport Co. Mayo.
Reporting to the Site Quality Director in this position you will lead a talented and experienced team of quality professionals including QPs to ensure adherence to an effective Quality Management System that maintains compliance with all global regulatory requirements. You will also interact with the global Quality group and with our site Leadership team delivering on our key strategic initiatives influencing the sites growth and business decisions. Its a great opportunity for someone to work on AbbVies leading products.
A key site in the AbbVie network Westport houses an impressive range of technologies where we manufacture eyecare and ocular implants including aseptic manufacturing and filling for single and multidose products alongside our commercial biologics manufacturing business units that manufacture Botox Biologics and NPIs.
A comprehensive package including long-term incentives pension health and well-being incentives awaits. Did we tell you the role is based in Westport one of the Wild Atlantic Ways most picturesque and family-friendly towns
If you are interested in the opportunity and want to learn more please apply and we will contact you.
Here is a snapshot of your responsibilities:
- Oversee all quality assurance activities within the manufacturing area ensuring compliance with regulatory standards and advancing product quality through strategic initiatives
- Manage and motivate all employees through effective communication coaching and influencing skills.
- Hold performance review meetings and manage staff performance according to company policy.
- Maintain resources and staff capacity in line with business needs including the recruitment and management of staff.
- Coach and develop QPs and Quality staff to support the Companys succession planning and Individual Development Plans (lOPs).
- Create foster implement and sustain the culture of Quality across the site and wider organisation.
- Foster a strong working relationship with relevant global functions as it relates to the performance of the companys quality system.
- Support the site Director of Quality The Business Unit Director in the development and deployment of relevant Site Business & Quality Plans.
- Lead the team which includes Qualified Persons Quality Compliance Analysts & Product Release and Product Certification Personnel.
- Demonstrate active involvement in the BU functional team by building a strong team and providing training and development opportunities for all team members with an ethos of One Operations Quality.
- Represent the company in regulatory inspections/assessments and assist with audit readiness as required
- Partner with the Business Unit Directors & Quality Systems and Compliance Director to drive continuous improvement initiatives at the site for the advancement of the quality system
- Drive the importance of a strong quality culture for the positive benefit of the site in producing high-quality products with reduced efforts in terms of addressing non-compliance.
- Direct manage and provide guidance to Business Unit Quality personnel site QPs and all functions pertaining to the compliant and effective performance of the Business Units.
- Plan and deploy resources and assignments as required prioritise competing activities and manage resources accordingly.
- Represent the company in all Business Unit Ministries of Health inspections ensuring the Unit is audit-ready.
- Ensure any non-conformances and open commitments related to the Business Unit are addressed.
- In conjunction with the Compliance department plan and conduct the Monthly quality system meetings and quarterly local and global Senior Management Review meetings as required as it relates to quality system performance.
Qualifications :
- BS/MS in Scientific Discipline.
- 8 years proven experience in a QA leadership role within GMP small molecule manufacturing operations (Biologics experience also highly desirable).
- QP Qualification required education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
- In-depth understanding of global GMP regulations and guidelines (e.g. EU MHRA FDA).
- Demonstrated success managing QA Operations and/or QA Compliance teams in a manufacturing setting.
- Strong leadership and interpersonal skills with the ability to engage and influence cross-functional peers.
- Experience supporting regulatory inspections and driving audit readiness.
- Excellent problem-solving communication and stakeholder management abilities
- Previous experience as a hands-on leader with managerial experience of leading inspiring and empowering team members.
- Proficiency with commonly used word processing database systems doc management and other routinely used quality systems and software.
- Exemplary cross-functional partnering and collaboration skills.
- Practical working knowledge and experience in the Pharma/Biotech industry in design controls and risk management principles and related activities.
- Experience in leading and managing regulatory inspections with Global Health Authorities and in interacting with and representing the company to Health Authorities their agents or related entities.
- Excellent analytical communication managerial and leadership skills.
- Ability to use sound judgment to make effective decisions within appropriate timeframes
- Proven to be self-directed self-motivated and able to prioritise competing priorities.
AbbVie is an Equal Employment Opportunity Employer; we value bringing together individuals from diverse backgrounds to develop innovative solutions for patients and being part of an inclusive work environment.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Employment Type
Full-time
