Director Quality Assurance

Biopharma Careers; Beerse; Sur place; EUR 119 000 - 204 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson Innovative Medicine Supply Chain Beerse is recruiting a QA Director Commercial Drug Product & Qualified Person to join the Quality management team in Beerse, Belgium. You will oversee manufacturing quality for Drug Products and ensure compliance with global regulations.

The role leads a team of QA managers, partners with Supply Chain and global Quality teams, and drives risk-based decision making to secure patient safety and continuous supply.

Qualifications

• Master's degree in Pharmaceutical sciences or equivalent.
• EU-certified Qualified Person.
• At least 10 years' experience in Chemical/Pharmaceutical Supply Chain or Quality.
• Fluent in Dutch and English.
• Proven leadership across cross-functional teams.

Responsabilités

• Lead QA managers and professionals to meet quality and business goals.
• Maintain relationships with Supply Chain and Quality partners for alignment.
• Act as QA point of contact for commercial Drug Products and ensure timely release.
• Represent Quality in governance meetings and drive continuous improvement.
• Apply Quality Risk Management tools to mitigate risks.

Connaissances

Quality management

GMP knowledge

Leadership

Risk assessment

Regulatory knowledge

Formation

Master in Pharmaceutical sciences

EU certified Qualified Person

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: People Leader

All Job Posting Locations: Beerse, Antwerp, Belgium

Job Description

Within Johnson & Johnson Innovative Medicine Supply Chain, we are recruiting a QA Director Commercial Drug Product & Qualified person as member of our Quality management team overseeing Pharmaceutical Drug product manufacturing based in Beerse, Belgium.

J&J Innovative Medicine Supply Chain Beerse serves as Centre of Excellence for the development and manufacturing of Pharmaceutical Drug Products used in treatments that improve the health and lifestyle of people worldwide. The Supply Chain Quality (SCQ) team supports the Beerse site in its mission as Launch & Grow site and is responsible for the quality oversight and final release of Drug Products guaranteeing reliable supplies in compliance with applicable regulations.

Responsibilities

• Lead a team of QA managers and professionals by supporting, coaching and developing team members in reaching quality, business and personal objectives.
• Establish and maintain strong working relationships with Business Partners in Supply Chain as well as local and global Quality partners to ensure alignment of objectives and results. Strengthen the Quality Culture in the supporting departments by providing coaching and/or training on cGMP requirements.
• Act as QA Point of Contact for commercial Drug Products ensuring timely release in compliance with global regulations and J&J quality requirements.
• Represent Quality in review meetings governing Quality and Compliance metric and operational business performance of the Quality Unit. Identify trends and define actions ensuring continuous improvement of the Quality and Compliance performance at the site in an effort to continuously strengthen the Quality Culture of the organization.
• Apply Quality Risk Management tools in order to proactively detect risks and define mitigation plans by risk-based decision making balancing business implications with Quality and Compliance requirements. Ensure that risks with potential impact on patient safety and/or product supply are properly escalated.
• With focus on Quality activities, provide strategic direction and foster an environment of innovative thinking through e.g. benchmarking, training, participating in industry fora. Continuously challenge the status quo by finding opportunities for continuous improvement. Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.
• Review and approve procedures and work instructions.
• Ensure that quality records such as investigations, CAPAs, Change Controls are timely and properly handled by providing quality, compliance and technical expertise such that the internal and external customer expectations are met.
• Ensure that deviations with potential impact on patient safety and/or product supply are properly escalated.
• Remain current in knowledge and skills towards regulatory and industry trends.
• Act as spokesperson during Health Authority inspections and customer audits.

Job Qualifications

• Master Scientific degree (Pharmaceutical sciences, Medicines, Biology or equivalent)
• EU certified Qualified Person
• At least 10 years’ experience in Chemical and/or Pharmaceutical Supply Chain and/or Quality.
• Fluent Dutch and English
• Ability to provide strategic leadership to meet business objectives in a highly dynamic business environment.
• Ability to work independently while staying connected with key stakeholders.
• Proven track record to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels of the organization are important.
• People leadership skills, experienced team leader for Supply Chain or Quality team.
• Proven Innovation Leader who enables creative thinking and drives implementation balancing pragmatism within a GMP framework.
• Strong analytical thinking skills and able to work in a flexible way under time pressure. Ability to make risk-based decisions under time pressure. Understands the business implications regarding quality positions and decisions.
• Ability to quickly assimilate new modalities and technologies, perform risk assessments and develop action plans.
• In-depth knowledge in GMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with regulatory inspections and preparedness.

Required Skills

Required Skills:

Preferred Skills

• Compliance Management, Consulting, Corrective and Preventive Action (CAPA), 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), Succession Planning, Tactical Thinking

The anticipated base pay range for this position is: €119200,00 - €204355,00

Benefits

• annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• vacation days
• parental leave for a minimum of 12 weeks
• bereavement leave
• caregiver leave
• volunteer leave
• well-being reimbursement
• programs for financial, physical and mental health
• service anniversary and recognition awards
• subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.