Position Overview

We are seeking an experienced and highly skilled GMP and ISO 13485 Production Manager to lead and optimize our production operations in a regulated environment. This role requires a strategic leader with expertise in GMP and ISO 13485 standards, a strong commitment to "right-first-time" principles, and proficiency in Swedish, Danish, and Englishto effectively manage cross-border operations and communicate with stakeholders. With a minimum of 10 years of relevant experience, the ideal candidate will drive operational excellence, implement LEAN methodologies, and maintain exceptional quality standards while liaising closely with customers and internal teams.

Key Responsibilities

• Production Leadership and Optimization
• Manage and oversee all aspects of production, ensuring products are delivered on time, within budget, and to the highest quality standards.
• Develop and implement robust production schedules, workflows, and SOPs to optimize productivity and minimize downtime.
• Promote and uphold a "right-first-time" culture to reduce errors, waste, and rework across all processes.
• Regulatory Compliance
• Ensure full compliance with Good Manufacturing Practices (GMP) and ISO 13485 standards, maintaining readiness for regulatory audits and inspections.
• Prepare and maintain detailed documentation to support regulatory requirements and ensure traceability of production activities.
• Oversee validation processes, equipment qualification, and compliance with global regulatory expectations.
• LEAN Manufacturing and Continuous Improvement:
• Implement and sustain LEAN manufacturing principles to streamline operations, improve efficiency, and reduce waste.
• Utilize data-driven decision-making to identify and implement process improvements that enhance productivity and quality.
• Monitor and analyze key performance indicators (KPIs) to ensure continuous improvement initiatives deliver measurable results.
• Customer Liaison and Stakeholder Collaboration:
• Serve as the primary point of contact for customers regarding production timelines, quality standards, and specific requirements.
• Build and maintain strong relationships with customers, proactively addressing concerns and ensuring satisfaction.
• Collaborate with internal teams (R&D, Quality, Supply Chain, Engineering) to align production activities with strategic objectives.
• Quality Assurance and Risk Management:
• Collaborate closely with QA/QC teams to ensure robust quality systems are in place and adhered to at all times.
• Identify potential risks in the production process and implement corrective and preventive actions (CAPAs) to mitigate them.

• Team Leadership and Development:
• Lead, mentor, and develop a high-performing production team, fostering a culture of accountability, innovation, and collaboration.
• Conduct regular training sessions to ensure the team is proficient in GMP, ISO 13485, LEAN practices, and other relevant skills.
• Set clear performance goals, provide constructive feedback, and support professional growth within the team.
• Health, Safety, and Environmental Compliance:
• Ensure all production activities adhere to health, safety, and environmental regulations, conducting regular risk assessments.
• Drive a culture of safety awareness and implement measures to mitigate workplace hazards.
• Operational and Financial Management:
• Manage production budgets effectively, ensuring cost efficiency without compromising quality or timelines.
• Oversee procurement of materials and resources, maintaining optimal inventory levels and minimizing costs.

Qualifications and Experience

• Education:
• Bachelor’s degree in Engineering, Life Sciences, or a related field. A Master’s degree or equivalent qualification is a strong advantage.
• Experience:
• At least 10 years of production management experience in a regulated GMP and ISO 13485 environment, preferably in the pharmaceutical or medical device industries.
• Proven track record of successfully managing production teams and delivering results in a dynamic, high-pressure environment.
• Language Skills:
• Proficiency in Swedish, Danish, and English is required to manage cross-functional teams and liaise effectively with regional stakeholders.
• Technical Skills:
• Extensive knowledge of GMP and ISO 13485 standards, quality systems, and validation processes.
• Expertise in implementing and managing LEAN manufacturing principles and practices.
• Strong analytical skills with the ability to interpret data, identify trends, and drive decision-making.
• Leadership and Communication:
• Exceptional leadership skills with a proven ability to inspire, develop, and manage diverse teams.
• Strong interpersonal and communication skills to engage effectively with internal teams, customers, and external stakeholders.
• Problem-Solving and Innovation:
• Results-driven with a proactive and innovative approach to addressing challenges and identifying opportunities for improvement.

What We Offer

• Competitive salary and benefits package.
• Opportunity to work in a dynamic, multinational environment with cutting-edge technologies.
• Professional growth and development opportunities within a leading global organization.

Application Process

If you are an experienced and results-driven production manager with a passion for operational excellence and compliance, and proficiency in Swedish, Danish, and English, we invite you to apply. Please submit your CV and a cover letter detailing your achievements and experience relevant to this role.