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Senior Quality Manager (all gender)

Company Description

We are the designers of today for the world of tomorrow.

As one of the world's leading engineering service providers, we at ALTEN are committed to positively shaping the future of our partners, the careers of our employees and the challenges facing our society and environment.

More than 50,000 employees in 30 countries are already working on innovative solutions in various engineering and IT sectors such as automotive, aerospace, renewable energy, medical technology and railway technology.

Job Description

YOU…

  • are responsible for planning, oversight and management of the Control Procedure (CP) system within CQF in accordance with the GMP regulations and internal data management systems (e.g. CONDOR)
  • evaluate and implement pharmacopoeial changes
  • take over the change management/coordination of CPs with respect to compendial testing, internal testing and specification, etc.
  • coordinate CP-related projects with internal and external business partners
  • plan and implement periodic reviews of CPs within CQF in close collaboration with the QA and QC
  • collaborate and optimize cross-functional activities regarding CPs (QSS, QC labs, etc.) and in other GMP work streams
  • are leading projects to optimize workflows, authoring SOPs
  • participate and preparate inspections and audits by customers and health authorities
  • are the expert support for QC, Production, Registration and QA
  • handling questions and requests (e.g. translations) from health authorities and Registration
  • lead and support deviation investigations pertaining to control procedures
  • support implementing CAPAs pertaining to control procedures (e.g. from OOS or deviation cases)
  • take over the management of external laboratories in topics relating to CP updates
  • will be responsible for general administrative and organisatorial tasks
  • create and manage reports

Qualifications

YOU…

  • have an academic background with natural science/technological background or equivalent education
  • have relevant professional experience in a GMP environment or equivalent
  • are able to make complex decisions
  • already have some knowledge of the business area
  • have knowledge of GMP principles
  • are quality and results driven
  • are highly self-motivated and structured in daily work
  • have strong communications skills
  • are a team player and Customer oriented
  • can work with MS Office- and other standard IT-applications
  • are fluent in German and English (oral and written)

Salary starting at € 4.000 gross per month based on 38.5 h/week with the express willingness to overpay depending on qualifications and experience.

We value diversity and therefore welcome all applications – regardless of gender, nationality, ethnic and social origin, religion/belief, disability, age and sexual orientation and identity.

Severely disabled persons will be given preferential consideration if they are equally qualified.

Do you have any questions? 

Then contact me: Suada Cisic Salkovic (+43 699 14148502).

Or apply now using our online application form.

Additional Information

  • .Talent Management - we develop your career
  • Work life balance - flexible working hours and mobile working possible

...and of course we offer the usual standards such as 25 days' holiday, many events, permanent employment contract and corporate benefits.

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Average salary estimate

$54000 / YEARLY (est.)
min
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$48000K
$60000K

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What You Should Know About Senior Quality Manager (all gender), ALTEN

Join us at ALTEN as a Senior Quality Manager and be a key player in shaping the future of engineering and technology! Based in the charming town of Schaftenau, Austria, you'll dive into a dynamic role responsible for the planning, oversight, and management of the Control Procedure (CP) system, all while adhering to GMP regulations and internal data management systems. Your insights will guide the evaluation and implementation of pharmacopoeial changes and coordination of CPs across various testing and specifications. Collaborating closely with our internal Quality Assurance (QA) and Quality Control (QC) teams will allow you to optimize cross-functional activities, lead project initiatives for workflow enhancements, and ensure compliance during inspections and audits by customers and health authorities. With your solid academic background in natural sciences or technology and relevant professional experience in a GMP environment, you'll be working in a supportive atmosphere where your decisions matter. As someone who thrives on communication and teamwork, you'll engage confidently with QC, Production, and Registration teams while handling queries from external partners. Here at ALTEN, we appreciate diversity and promote an inclusive workplace, welcoming all applicants. If you’re looking to bring your expertise into a role that prioritizes quality and results, this is where you belong! Salary starting at €4,000 gross monthly for a 38.5-hour workweek, with potential for more based on experience. Ready to step into this exciting opportunity? Don’t hesitate to reach out or apply now!

Frequently Asked Questions (FAQs) for Senior Quality Manager (all gender) Role at ALTEN
What are the main responsibilities of the Senior Quality Manager at ALTEN?

As a Senior Quality Manager at ALTEN, you will be primarily responsible for planning, oversight, and management of the Control Procedure system, ensuring compliance with GMP regulations. This includes evaluating pharmacopoeial changes, coordinating CP-related projects, and leading efforts to optimize workflows across various QC and QA activities.

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What qualifications are necessary for the Senior Quality Manager position at ALTEN?

To qualify for the Senior Quality Manager role at ALTEN, applicants should possess an academic background in natural sciences or technology, along with relevant professional experience in a GMP environment. Knowledge of GMP principles, strong communication skills, and proficient use of MS Office are also essential.

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How does ALTEN support the professional development of a Senior Quality Manager?

ALTEN is committed to talent management and career development, providing resources and opportunities for professional growth. As a Senior Quality Manager, you will have access to flexible working hours, mobile working options, and various corporate benefits that help balance work and personal life.

Join Rise to see the full answer
What are the key skills required for a Senior Quality Manager at ALTEN?

Key skills for a Senior Quality Manager at ALTEN include the ability to make complex decisions, strong organizational skills, and a results-driven mindset. Additionally, being a team player with fluency in both German and English is vital for effective collaboration in this role.

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What does the salary package look like for the Senior Quality Manager position at ALTEN?

The salary for the Senior Quality Manager at ALTEN starts at €4,000 gross per month for a 38.5-hour workweek. The company expresses a willingness to consider higher compensation based on qualifications and experience, ensuring that your expertise is recognized and rewarded.

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Common Interview Questions for Senior Quality Manager (all gender)
Can you explain your experience with GMP regulations as a Senior Quality Manager?

In your response, highlight specific experiences managing GMP compliance, such as overseeing control procedures, evaluating pharmacopoeial changes, or leading audits. Discuss how you've navigated challenges in maintaining compliance and contributed to quality assurance efforts.

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How do you handle audits and inspections in a GMP environment?

Share examples of preparations you've undertaken for audits, such as coordinating with various departments for documentation, conducting internal reviews, and ensuring all control procedures meet compliance standards, detailing strategies for effective collaboration.

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Describe a time you managed a project to improve workflow. What was your approach?

Use the STAR method (Situation, Task, Action, Result) to outline a relevant project. Discuss how you identified the need for improvement, the actions you took to implement changes, and the positive outcomes that resulted from your initiative.

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How do you ensure effective communication among cross-functional teams?

Discuss your strategies for fostering open communication in cross-functional teams, such as regular meetings, transparent documentation practices, and using collaborative tools. Emphasize the importance of each team member's input in achieving quality goals.

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What strategies do you use for change management in control procedures?

Explain your approach to managing changes within control procedures, covering the steps involved—from assessing the validity of the change to communicating it effectively to all stakeholders, ensuring thorough documentation and training when necessary.

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How do you prioritize tasks and manage your time effectively as a Senior Quality Manager?

Outline your time management techniques, emphasizing the importance of setting clear priorities based on project deadlines, stakeholder needs, and compliance timelines. Share tools or methods you utilize to remain organized.

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What steps do you follow in deviation investigations?

Describe your systematic approach to handling deviations, from identifying the root cause to developing corrective actions and preventive actions (CAPAs). Mention your collaboration with QA and QC teams in resolving issues.

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How do you stay updated on industry trends and regulatory changes in GMP?

Talk about your commitment to continuous learning, such as attending relevant seminars, participating in industry networks, and reading professional publications. Explain how you apply this knowledge to your work as a Senior Quality Manager.

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Can you discuss a successful team project you led as a Senior Quality Manager?

Provide an example of a successful project where you led a team, detailing your leadership style, the challenges faced, and how you motivated the team towards achieving collective goals successfully.

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What qualities do you believe make an effective Senior Quality Manager?

Discuss essential qualities such as integrity, attention to detail, strong leadership and communication skills, adaptability, and a commitment to promoting a culture of quality within the organization, giving examples from your experience.

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European businesses that get tangled up in technology can avail themselves of ALTEN's services. The company provides a variety of engineering and technology consulting services for clients primarily in France. It also operates in Germany, the Bene...

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DATE POSTED
April 15, 2025

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