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JOB POSITION SUMMARY

Quality assurance of chemical and microbiological testing and controls performed on products, raw materials/input materials, media, and manufacturing processes (including environmental hygiene), as well as quality assurance of validation and maintenance activities within the chemical and microbiological laboratory.

Process Owner for the UQC/UQM laboratory process.

Equipment Owner for laboratory systems within UQC/UQM.

Review and approve documentation, test methods, and processes for the Quality Control laboratory.

Review and approve laboratory investigations and non-conformity investigations.

Replace Head of UQ during short-term absences, in accordance with a specific delegation of authority.

DUTIES & RESPONSIBILITIES

Lead and develop the laboratory to ensure that AMO Uppsala AB and UQ achieve their objectives regarding quality & compliance, delivery reliability, and cost efficiency.

Plan and allocate resources and budget for QC Chemistry, Incoming Goods Inspection, and Microbiology.

Responsible for cost centers 1213203550 and 1213203650 in accordance with the company's current approval authority policy.

Line management responsibility for QC Chemistry, Incoming Goods Inspection, and Microbiology, as delegated.

Member of the Quality Leadership Team.

Ensure that all required chemical, physical, and microbiological tests and controls are performed on products, raw materials/input materials, media, and manufacturing processes in accordance with pharmacopoeial requirements and other applicable regulations.

Ensure that processes are validated and qualified within the chemical and microbiological laboratories, as well as maintenance and calibration activities are in compliance with applicable requirements.

Review and approve documents related to chemical, physical, and microbiological testing, test methods, and annual summaries/reports.

Review and approve assessments and rationales related to chemical and microbiological testing and results.

Review and approve investigations related to laboratory investigations and non-conformities.

Ensure support and maintenance of quality specifications for products.

EXPERIENCE & EDUCATION

Five-year university degree in microbiology, chemistry, pharmacy, natural sciences, engineering, or a related field, or equivalent professional experience within the pharmaceutical industry or another process industry.

Relevant leadership training for the position.

Basic knowledge of financial accounting and budgeting.

At least three to five years of professional experience in quality-related work within a quality-certified laboratory or manufacturing environment.

Experience in project management.

Experience in people management and leadership.

Strong knowledge of GMP (Good Manufacturing Practice) and/or ISO standards, as well as applicable regulations and guidance documents (e.g., CFR, pharmacopoeias).

Good IT skills.
Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity

Proficiency in both Swedish and English, spoken and written.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS

Detail-oriented

Able to perform effectively under pressure

Goal-oriented

Structured and organized

Strong communication skills

Proactive and results-driven

Well-organized

Flexible and adaptable

Easy to collaborate with and able to communicate effectively both verbally and in writing

Self-motivated and capable of working independently

Strong initiative and drive

High level of integrity

Efficient working style

Ability to apply situational leadership

Ability to plan and prioritize departmental objectives as well as own work

Ability to collaborate across functions and departments while maintaining a holistic business perspective and understanding of the bigger picture.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an 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. Moreover, we offer 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. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

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