Manager Quality Assurance/Quality Systems

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Uppsala, Uppsala County, Sweden

Job Description:

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/

J&J MedTech is recruiting for a Manager Quality Assurance/Quality Systems reporting to the Quality Director and to be based in Uppsala (Sweden).

In Uppsala, we manufacture Healon, a market-leading product used to stabilize the eye in connection with eye surgery. Upon its launch in 1980, Healon paved the way for safe and quick eye surgery, whereby a patient’s cataracts can be replaced with new lenses in just a few minutes.

JOB POSITION SUMMARY

Quality assurance of Product, Raw materials, Media and Manufacturing processes.

Process Owner for the Release Process, Document/Change control Process, Validation Process, Training Process and Labeling Process. Operational planning, resource planning and KPIs are carried out within Uppsala Quality Assurance team.

Ensure that appropriate Quality Systems and Controls are in place for monitoring and detecting deviations in critical processes.

Ensure that responsibilities and authority and working methods within Uppsala site are regulated by written procedures that comply with applicable regulations. Operate in accordance with applicable regulations and standards, as well as GMP requirements for the markets where AMO Uppsala's products are marketed.

Overall cost center responsibility for the Quality Assurance team. This position is also operative within the Quality Assurance team responsibilities (70/30: Operative/Strategic position).

DUTIES & RESPONSIBILITIES

Duties for Manager QA/QS involve the following areas:

• Quality Management - Develop and improve quality management processes and ensure that quality management processes within AMO Uppsala meet Division / company requirements.
• Ensure that appropriate quality systems and controls are in place for monitoring and detecting deviations in critical processes, premises and equipment in accordance with Uppsala Quality Assurance’s functional description.

• Ensure that appropriate routines and controls are implemented within the areas of responsibility, Release, Document Control, Change Control, Training, Labelling, Validation and Computer System Validation.

• Product release: Ensure that the basis for disposition decisions regarding media, raw materials, pre-treated components, substance and products are implemented in accordance with the applicable regulatory requirements and that there is qualification program

• Ensure Quality assurance of non-conformances and CAPAs. This includes investigations, product dispositions, approvals, verifications, evaluations. EM, Audit investigations, actions, effectiveness monitoring

• Management review - Compile and report documentation for management review related to the area of responsibility.
• Internal and External inspections: Assist site management during inspections and participate directly in audits with respect to responsibility areas.
• Ensure resources to conduct training in ISO/GMP / QMS.
• Ensure support site compliance with training SOPs together with training coordinators.
• Validation. Ensure support that validated and qualified processes in manufacturing are maintained. Review and approval of validations.
• Delegated responsibility on behalf of Quality Director as needed.
• Participation in local and global Quality Projects or initiatives.
• Ensure that the periodic review process within Quality is in compliance.
• Ensure Quality assurance resources for projects with respect to responsibility areas.
• Ensure support Records management and retention process.
• Ensure resources for support that the Labelling and artwork process is maintained with respect to responsibility areas.

EXPERIENCE&EDUCATION

• Academic education with scientific or technical orientation (3 to 5 years Academic education).
• Relevant leadership training for the position.
• Basic knowledge of financial accounting and budgeting
• At least five years of work experience from Quality Assurance/Quality systems (release, document control, change control, Training and validation) within pharmaceutical and/or Medical Devices organizations (ISO 13485/GMP)
• Experience in project management.
• Experience with implementation of requirements for GMP/ISO knowledge, as well as knowledge of regulations and guidances (e.g. ISO 13485, FDA CFR, pharmacopoeias).
• Good IT skills
• Good oral and written proficiency in both Swedish and English.

We are looking for a goal-oriented, structured, communicative and driven professional who would like to join our Quality Team.

Required Skills:

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management