Associate Principal QA Specialist (CQV)

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

To 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 escalate 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 SME support at departmental Local Quality Councils and project meetings

Provide QA project support to complex projects

Performs other duties as assigned., 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

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.

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