Are you our new Quality System Manager?

If you are excited to be part of a winning team and work in an international environment, we have an opportunity for you.

The Quality System Manager, who works under the direction and supervision of the Halden Site Quality Assurance Director, leads the planning and execution of projects and activities for the facility to improve product and process quality. They are responsible for leading, managing, and improving the following processes:

• Change Management
• Document Control
• Quality Improvement Projects

They will analyze quality data, such as complaints, process non-conformances, process capability, audit reports, etc, to identify and correct quality issues. The Quality System Manager will also be a key resource in identifying and implementing best practices for process improvement, problem solving, and driving customer satisfaction.

Description:

The Quality System Manager will be responsible for managing multiple employees within the Halden Quality Assurance team. This individual is responsible for leading, managing, and improving the following quality systems: Change Management, Document Control, and Technology Transfer. They will be responsible for leading change control meetings, supporting quality improvement project through technology transfer, and leading the document control team. 

The support to Halden operations will include providing daily guidance on Good Manufacturing Practices (cGMPs) and effective risk management. This position is hands-on in a fast-paced environment which interacts with multiple functions (QC, Production, Purchasing, Engineering, Regulatory Affairs, etc.) and other internal sites (sister manufacturing sites and contract manufacturers) to resolve quality issues.

Main responsibilities

• Lead, manage, and improve the change management and document control processes for Halden improving credibility, consistency, and stability across the site. This includes data management activities.
• Provide subject matter expertise, support, and direction for the change control. Open, monitor, and track performance for all change control records.
• Coach Change Control and Document owners to ensure records are complete and documentation stands on its own during external review.
• Lead and drive harmonization activities for different quality system elements based on yearly global quality goals and initiatives.
• Support the yearly quality audit process conducting audits and corrective action plans.
• Support the planning, communication, preparation, and execution of all external inspection activities. The covers inspections from all regulatory authorities, customers, and our notified body. 
• Review documentation (records, procedures, work instructions, forms etc.) to ensure that they are accurate, complete and compliant with the process, and requirements of the quality management system / GMP.
• Collaborates with internal groups to ensure quality standards are in place and improvements are implemented according to defined plans.
• Ensures that corrective measures meet acceptable standards and that documentation is compliant with all regulatory requirements.
• Supervise, mentor, and direct professional development of all direct reports including succession/back-up plans.
• Legal Compliance; maintain and proactively ensure the process for legal compliance at the site by monitoring regulations and standards relevant to the pharmaceutical industry; ICH guidelines, cGMP, national regulations, ISO-standards (9001/13485) and corporate regulations.
• Provides support and input to the Q-KPI reporting tool for the site; communicate with the site at the Quality Circle meetings.
• Meet and quality and budgets goals for the Quality Systems department
• Demonstrate behavior consistent with the Company's Code of Ethics and Conduct. Ensure that direct reports) are trained and evaluated on their knowledge and adherence to the Company's values, Code of Ethics and Conduct, and applicable compliance policies

Expectation of achievement

• Quality issues are evaluated and reported in a timely manner to management when a field action or field alert might be required.
• Agreed budget is under control and any deviations are reported and explained.
• Communication and cooperation with customers, authorities, notified body and suppliers is professional, and any requests are responded to in a timely manner.
• Timely support to projects according to agreed timelines
• KPIs are within defined limits and action is taken when expectations are not met.
• High level of compliance for the Quality Assurance and Quality Systems team:
• No critical observations given during external inspections
• No recalls issued by Fresenius Kabi products
• No warning letter issued
• No field alerts/rapid alerts issued
• Supplier management is efficient and compliant.
• Annual performance and HSE conversations are performed annually and goals and are monitored as agreed.
• Personnel are trained and qualified to perform the tasks and responsibilities defined in their job descriptions.

REQUIREMENTS:

Education:

• Qualified individual should have a Bachelors Degree in Science in: Chemistry, Biology, Pharmacy, Engineering, Business, Mathematics, or technical field with emphasis on statistics and problem solving skills. Advanced degree preferred.

Experience: 

• Minimum 6 years of experience in Quality Assurance or related field in a regulated industry
• Minimum of 4 years of experience managing and improving Quality Systems (change management, configuration management, CAPA, internal audit, supplier quality, non-conforming product, etc.)
• Direct experience supporting and/or leading third party audits (ISO registrars, FDA or other regulatory authorities)
• Extensive Supplier/Internal audit experience
• Working Experience with EU or FDA cGMPs
• 21 CFR part 211 or Part 820, ICH Q7, EU GMPs, or ISO13485 preferred
• AS9100 or TS16969 Quality Systems will also be considered
• Superior leadership, facilitation, and communication skills
• Demonstrated implementation of continuous improvement methodologies
• Working knowledge of ISO Quality Management Systems
• Exposure to process and/or software validation methods
• Excellent communication and interpersonal skills
• Ability to work independently across multiple organizations
• Good report writing and reviewing skills

Desired Qualifications:

• ASQ Certificate: CMQ&OE, CQE, CQA, CQT, CBA, etc.
• Lead Auditor Certification and Training
• Operational Excellence/Six Sigma/Lean training or certifications
• Working knowledge of ISO quality management systems13485 and 21 CFR Part 820
• Project management certifications (Black Belt, Green Belt, Certified Associate in Project Management (CAPM), Project Management Professional (PMP), etc)
• Experience using Sparta Trackwise and/or SAP.

Personal characteristics

• Positive mind-set and an including attitude
• Good communication- and cooperation skills
• Proactive and goal oriented
• Organized and quality oriented
• Ability to make decisions

For more information about the position, please contact QA Director Wayne Aaron Snyder (Aaron.Snyder(a)fresenius-kabi.com)

Søknadsfrist 31. Juli 2021