Manager Quality Assurance Operations (m/f/d)

Sandoz in Deutschland; Holzkirchen; On-site; EUR 604,000 - 1,122,000; Full time

Benefits offered by this job

30 vacation days per year

1,200€ vacation payment

€40/month capital-forming benefits

Company pension

Flex-hybrid 50% office work

Learning platforms Skillsoft & Learnl

OurShare employee share program

Job summary

Sandoz in Holzkirchen, Germany is seeking a QA professional to manage GMP documents, support policy alignment and improve processes. The role covers batch release coordination, risk assessments, and deviation handling in a regulated biosimilar/generic medicines environment.

Ideal candidates have a basic scientific degree, knowledge of cGMPs and proficiency in German and English. The position offers a full-time, on-site role with hybrid options and a comprehensive benefits package.

Qualifications

• Basic degree in scientific, technical or relevant discipline.
• BS or equivalent education/experience.
• Basic scientific, technical and regulatory knowledge in a specific area.
• Good knowledge of cGMPs and working knowledge.
• Basic organization skills.
• Good knowledge in German and English.

Responsibilities

• Manage portfolio of projects, support a discipline and/or provide a service.
• Create and review GMP relevant documents in own area of responsibility (e.g. batch records for material manufactured and packaged internally, SOPs, procedures, records, third party work)
• Negotiate and clarify deficiencies in GMP documents in area of own responsibility with the line unit.
• Provide support to internal policies (GOPs, Manual), and global compliance initiatives.
• Develop and improve GMP processes to meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE etc.).
• Organize, coordinate Pest Control program tasks. Supervise external partners for pest control.
• Prepare reports and risk assessments in area of responsibility.
• Promote and enforce compliance to guidelines.
• Support inspections and audits and perform self-inspections and audits if applicable.
• Responsible for BRR and coordination of batch release.
• Support artwork changes as respective quality role.
• Responsible for Deviations and Complaints as QA representative.
• Management of quality data in SAP

Skills

GMP knowledge

Organization skills

German language

English language

Education

BS or equivalent

Job description

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!

Your Key Responsibilities

• Manage portfolio of projects, support a discipline and / or provide a service. If applicable, may provide functional expertise in area of responsibility.
• Create and review GMP relevant documents in own area of responsibility (e.g. batch records for material manufactured and packaged internally, SOPs, procedures, records, third party work)
• Negotiate and clarify deficiencies in GMP documents in area of own responsibility with the line unit.
• Provide support to internal policies (GOPs, Manual), and global compliance initiatives.
• Develop and improve GMP processes to meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidances, SOPs, HSE etc.).
• Organize, coordinate Pest Control program tasks. Supervise external partners for pest control.
• Prepare reports and risk assessments in area of responsibility.
• Promote and enforce compliance to guidelines.
• Support inspections and audits and perform self-inspections and audits if applicable.
• Responsible for BRR and coordination of batch release.
• Support artwork changes as respective quality role.
• Responsible for Deviations and Complaints as QA representative.
• Management of quality data in SAP

Essential Requirements

• Basic degree in scientific, technical or relevant discipline
• (BS or equivalent) or comparable education / experience
• Basic scientific, technical and regulatory knowledge in a
• specific area
• Good knowledge of cGMPs and working knowledge
• Basic organization skills
• Good knowledge in German and English

Compensation Structure & Criteria

Sandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.

• Job location: Holzkirchen, Germany
• Starting pay range: EUR 54,100 - 100,500
• Variable compensation: 5% performance-based bonus
• Additional benefits include: 30 vacation days per year (in full time), 1.200€ vacation payment (in full time), €40/month in capital-forming benefits (in full time), company pension, flex-hybrid working 50% per week in the office, access to our learning & development platforms Skillsoft & Learnlight, Access to our employee share program “OurShare”
• Pay frequency: Monthly
• Expected weekly working hours: 40 hours
• Contract type: full time

Why Sandoz?

Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!

Join us, help us make healthcare fairer and faster.

Commitment To Diversity & Inclusion

We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.

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