Manager Quality Assurance Operations (m/f/d)

DE71 (FCRS = DE071) HEXAL AG; Holzkirchen; On-site; EUR 54,000 - 101,000; Full time

Benefits offered by this job

Vacation days

Vacation pay (EUR 1,200)

Capital-forming benefits

Company pension

Hybrid work 50% in office

Skillsoft & Learnlight

OurShare employee share program

Job summary

HEXAL AG in Holzkirchen, Germany, seeks a QA Manager to lead QA projects, ensure GMP document integrity, and support deviations and complaints. You will coordinate with cross-functional teams to maintain environmental monitoring and pest control programs, and support regulatory inspections.

The role requires a solid foundation in GMP/regulatory knowledge, and fluency in German and English. The position offers a full-time role with hybrid work options and a competitive salary range.

Qualifications

• Basic degree in scientific, technical or relevant discipline.
• Good knowledge of cGMPs and working knowledge.
• Fluent in German and English.

Responsibilities

• Manage portfolio of QA projects and resources.
• Review and approve GMP documents and batch records.
• Support deviations, complaints and inspections as QA representative.
• Coordinate pest control and environmental monitoring activities.
• Ensure compliance with internal and external regulations.

Skills

German language

English language

Regulatory knowledge

Education

BS or equivalent in scientific/technical field

Tools

SAP

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.

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

What you’ll bring to the role

• 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.

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

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!