Senior Manager Quality Assurance/QP (Biologics)
In this role you will be responsible for the quality oversight for activities performed within the Biologics Manufacturing Business Unit at the Westport site, this role will include provision of appropriate resources & involvement in the following:
- GMP compliance;
- Release of batches that are safe, effective and per applicable requirements;
- Monitor relevant customer complaint performance and drive CAPA actions commensurate to risk;
- Provide quality oversight on key deviations/non-conformance issues within the business unit;
- Participate in GMP and other regulatory pre-approval inspections; assist with post-inspection commitments ensuring timelines are achieved in terms of implementation of process improvements;
- Maintain resources as per business needs including recruitment & management of staff;
- Support timely release of product to ensure patient supply is maintained;
- Change Management.
So let’s tell you a little more about this role…just a snapshot:
- Provide guidance to direct reports to ensure activities are completed as per defined timelines and in a GMP compliant manner;
- Manage, lead & motivate team members through effective communication and effectively assign responsibility and resources to achieve required goals;
- Coach and develop team members to support the Company's succession planning;
- Maintain strong relationships with management and colleagues in the business unit and the quality function, direct reports, and customers. Articulate the necessary quality requirements in a clear, concise, and persuasive manner;
- Represent the company in regulatory inspections/assessments and assisting with audit readiness as required;
- Partner with the Business Unit & QA 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;
- Foster an environment of continuous improvements for the site and the business unit by identifying and implementing efficiencies and quality improvements;
- Participate in required project meetings with E&T, Pharm Tech & Project Management functions as they relate to strategic and process improvement initiatives for manufacturing release projects;
- Participate in routine site quality monthly meetings, Weekly Customer Complaints meeting, EM Trends meetings as a QP and represent Business Unit at the CCRB;
- As a QP approve relevant business records including batch records, certificates of conformity, product quality reviews and NCRs.
To succeed in this role, you will have the following Education and Experience:
- Bachelor’s Degree in Industrial Pharmaceutical Science (QP) required;
- 5+ years’ experience in quality assurance, operations, regulatory or relevant experience. Including 2 years minimum direct people management experience;
- Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products;
- Strong influencing, motivational, interpersonal and relationship building skills at all levels;
- Excellent written and oral communication skills. Proficiency in English;
- Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded;
- Strong decision-making skills;
- Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
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