Manager Quality Assurance Operations (m/f/d)

(FCRS = PL013) Sandoz Poland Sp. z o.o.; Holzkirchen; On-site; EUR 50,000 - 93,000; Full time

Benefits offered by this job

30 vacation days

Vacation pay €1200

Capital-forming benefits €40/mo

Company pension

Flex-hybrid 50% office

Skillsoft Learnlight access

OurShare employee stock program

Job summary

Sandoz Poland Sp. z o.o. seeks a QA professional to manage projects and ensure GMP compliance across multiple departments. You will prepare GMP documents, support regulatory reviews, and handle deviations and complaints as QA representative.

The role requires a basic science degree, knowledge of cGMP, and fluency in German and English. The position is full-time with a hybrid work setup and competitive compensation.

Qualifications

• 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.

Responsibilities

• Manage portfolio of projects and support a discipline or service.
• Create and review GMP relevant documents (batch records, SOPs, procedures).
• Negotiate and clarify deficiencies in GMP documents with line unit.
• Provide support to internal policies and global compliance initiatives.
• Develop and improve GMP processes to meet guidelines (GMP, SOPs, etc.).
• Organize Pest Control program tasks and supervise external partners.

Skills

GMP knowledge

Organization skills

German

English

Education

BS or equivalent degree

Job description

Job Description Summary

Manage projects and / or processes and allocated resources to support departmental projects and objectives according to agreed timelines and standards and assure compliance with GMP. The projects run generally across the departments where the Manager QA often leads the project team.
Quality Compliance on shopfloor and especially in area of environmental monitoring and pest control.
Supports QP in timely release of GMP relevant documents by an appropriate review and addressing of gaps and questions.
Responsible for Complaint handling ensuring compliance to internal and external regulations.

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:

Your responsibilities include, but not limited to:

• 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

What you’ll bring to the role:

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:

• 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.

#Sandoz

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence