Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA Leadership. Provide oversight on day to day Quality Assurance activities in the areas of Validation / Technical Services in accordance with Lonza Corporate requirements, standards and current regulatory requirements, meeting USFDA, European requirements and others as applicable for a multi-product, GMP biotech contract manufacturing facility. To provide shoulder to shoulder review, approval and support for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations.
Primary Responsibilities
* Provide oversight over day to day Quality assurance activities in the areas of Technical Services and Validation in accordance with Lonza Corporate requirements, standards and current regulatory requirements.
* Utilize knowledge of GMP and quality processes within the functional areas to: Manage and escal
* Major and Critical compliance issues through the site QMS processes e.g. deviations and CAPAs
* To actively identify, suggest and participate in continuous improvement activities.
* Mentor and coach business partners in cGMP practices to maintain and develop a cGMP environment.
* Maintain and promote a state of audit readiness.
* Actively suggest, initiate, participate and contribute to PQS process improvements initiatives and projects.
* Provide QA SME support at departmental Local Quality Councils and project meetings.
* Provide shoulder to shoulder review, approval and QA Technical support to key business partners for the management of quality records e.g. Deviations, CAPA, Change Controls, Investigations.
* Provide coaching and training to other team members.
* Provide QA project support to complex projects.
* Performs other duties as assigned.
Customer & Performance Focus
Understands what internal and/or external customers need from him/her to deliver in his/her respective role.
Demonstrates an openness to receiving customer feedback.
Takes action to enhance customer satisfaction within the scope of his/her role.
Consistently delivers goals while monitoring KPIs with supervisor.
Demonstrates persistence and motivation to overcome obstacles and challenges.
Skills & Attributes
* Ensures quality standards are maintained while delivering results.
* Plans, prioritizes and organizes work to deliver on time.
* Takes responsibility for his/her safety and that of others.
* Takes responsibility for personal choices and behaviors.
* Seeks feedback and reflects on his/her development needs in order to continuously improve.
* Demonstrates an ability and desire to learn from experience.
* Treats errors as a learning opportunity.
* Is willing to take on new challenges.
* Takes steps to adapt thinking and behavior to support change.
* Seeks to understand the corporate strategy and how his/her business area contributes to the company s success.
* Understands the impact of his/her own actions on his/her business area.
* Uses knowledge of his/her business area to make accurate and timely decisions.
* Acts as a reliable and dependable member of the team.
* Excellent decision-making and problem solving skills.
* Strong Quality mindset.
* Strong business and interpersonal skills and be a persuasive communicator in written, oral and active listening to influence peers and colleagues.
* Strong Continuous Improvement mindset.
* Excellent communication skills (verbal and written).
* Ability to meet strict deadlines.
* Excellent organizational and planning skills.
Qualifications
* Education/Degree: Scientific
* Work Experience Area: QA
* Level- Advanced: 5-10 years
Other Requirements
* IT literate, Familiarity with database entries, verbal and written communication skills, risk based decision making, PQS experience.
* Conforms to general site quality responsibilities.
* Conforms to safety responsibilities.
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