Sr. Specialist External Quality

Biopharma Asia; Latina; Hybrid; EUR 49,000 - 78,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson in Latina, Italy, is seeking an External Quality Senior Specialist to uphold top quality and compliance for externally manufactured drug products. You will collaborate with the External Quality Site Lead to ensure product quality and patient supply.

The role emphasizes cGMP, ICH, regulatory expectations, and continuous improvement across external manufacturers and strategic partners, including audits and capacity planning. Travel up to 25% may be required.

Qualifications

• Bachelor’s degree in Pharmacy, Science, Engineering or a related technical discipline.
• Minimum of 4 years in quality management or related pharmaceutical/biotech environment.
• Experience in GMP, cGMP, ICH requirements and health authority expectations.
• Ability to review quality records, identify gaps and drive CAPA and risk-based decisions.
• Strong communication and ability to work with internal and external partners.

Responsibilities

• Provide QA support and oversight for externally manufactured products and related activities.
• Review deviations, investigations, CAPAs, change controls, complaints and release records.
• Monitor supplier quality using metrics and audit outcomes.
• Collaborate with cross-functional teams to meet registered requirements and patient supply needs.
• Support audits, inspections and regulatory commitments with external manufacturers.

Skills

Quality Assurance

GMP

CAPA

Regulatory Compliance

Project Collaboration

Education

Bachelor’s degree in Pharmacy or related field

Tools

Microsoft Office

QMS Software

Job description

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.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Belgium R-109826, Italy R-109827, Switzerland R-109772

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Function

Quality

Job Sub Function

Quality Assurance

Job Category

Professional

All Job Posting Locations

Latina, Italy

Job Description

External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners.

In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our Synthetic products, specifically focusing on Drug Products, produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do!

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Essential Job Duties and Responsibilities

This role supports business, quality and compliance objectives for externally manufactured Synthetic drug products, ensuring activities are performed in accordance with J&J policies, enterprise standards, quality agreements, cGMP requirements, ICH expectations and applicable regulatory commitments.

The Senior Specialist EQ provides quality assurance support and oversight for external manufacturers and strategic partners involved in Synthetic drug substance and/or drug product manufacturing, packaging, testing, release, stability and supply activities, while helping to maintain product quality, compliance and reliable patient supply.

Key Responsibilities

• Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
• Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
• Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
• Identify, communicate and escal…
• Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
• Collaborate with External Quality Site Leads, Product Quality, MSAT, Planning, Procurement, Regulatory, EHS, Qualified Persons and external partners to ensure registered requirements and patient supply needs are met.
• Support external manufacturers during J&J audits, health authority inspections and regulatory commitments, including preparation, response review and follow-up of agreed actions.
• Participate in technology transfer, new product introduction, product lifecycle management, process improvement and risk management initiatives for Synthetic products.
• Contribute to continuous improvement of External Quality processes, documentation practices, quality culture and performance management across internal and external stakeholders.

Minimum Qualification

• Minimum of a Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline.
• Minimum of 4 years of experience in quality management, quality assurance, production, quality control, R&D or a related pharmaceutical and/or biotechnology environment.
• Experience working in a GMP-regulated environment, preferably including quality support for external manufacturing, drug product or drug substance manufacturing, packaging, testing, release or commercial supply.
• Working knowledge of cGMP, ICH requirements, quality systems and applicable health authority expectations.
• Ability to review and assess quality records, identify gaps, support root cause analysis and contribute to effective CAPA and risk-based decision-making.
• Excellent verbal and written communication skills, including the ability to communicate effectively with internal functions and external partners.
• Ability to work independently with minimal supervision, manage multiple priorities, meet tight timelines and maintain a collaborative and professional approach.
• Excellent computer proficiency, including Microsoft Office and standard quality system tools.
• Experience with deviation, CAPA, change control, complaint, batch release, quality agreement, audit or inspection support processes.

Preferred Qualification

• Experience working with external manufacturers, contract manufacturing organizations, external contract laboratories or strategic partners.
• Experience working on cross-functional project teams.
• Experience with product transfer, new product introduction, parenteral, and/or combination products.

Other

This role may require up to 25% of domestic & international travel.

Preferred Skills

Business Alignment, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)

The anticipated base pay range for this position is

€49’100.00 - €78’200.00

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.