Manager Quality Assurance (m/f/d)
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
- 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
- Act in role of Investigator or QA representative for Deviations
- Prepare reports and risk assessments in area of responsibility
- Promote and enforce compliance to guidelines
- Perform walkthroughs on shopfloor
- Responsible as first line of QA\-support for shopfloor
- 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
- Support all quality\-related activities in Development to ensure compliance with the systems and policies
- Support the implementation and monitor quality upgrade programs within development
- Support, implement and monitor quality\-related global tools, processes and standards (e.g. GOPs, Novartis Quality Manual etc.)
- Ensure review and approval of quality\-related documents (e.g. Specifications, validation protocols and reports etc. according to QCM Responsibility\& Signature List)
- Support\& guidance to project teams to ensure quality output
- Support transfers from/to development
- Provide support in all development items for deficiency letter answering
Essential Requirements:
- At least 2 years’ experience in a GMP approved quality control laboratory
- Preferably 4 years work experience in GMP environment, preferably in different areas (e.g. QA, Production, Process development, Reg. Affaires)
- At least 2 years’ experience in product development and analytics and/or quality control and/or quality assurance with knowledge in product management
- Thorough knowledge of cGMP, national pharmaceutical legislation and regulatory guidelines
- Adequate presentation and scientific/technical writing skills
- Advanced organizational and communication skills
- Knowledge of software and computer tools relevant for pharmaceutical development
- Fluent in German (oral and written)
- Fluent English required (oral and written)
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: 15% 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
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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