Associate Director
vor 1 Tag
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Our site in 1210 Vienna is a strategic location for solid drug manufacturing including tablets, coated tablets, granules and implants for the health provision and treatment of livestock and domestic animals. Most of our products are exported. To ensure sustainable company growth we continually strive to offer attractive career opportunities for more than 450 employees at our Vienna site. In support of our existing team we are currently looking for:
Associate Director - Quality Assurance / Product Quality (M/F/d)
Main Responsibilities
Leading and coaching a Quality team of approximately 10 Quality Assurance experts (incl. Qualified persons) to provide end-to-end QA oversight for Drug Product throughout the project lifecycle. Team's main responsibilities are related to Product Quality review, stability assessments, drug product specification approval, Product Quality Complaints, Product change controls, QP certification, QA reviews for documents etc.
Facilitating and participating on cross-functional teams to collaboratively address issues and achieve project milestones, in compliance with cGMP, regulations, and Quality Management System
Providing guidance, consulting, interpretation of GMP and regulatory requirements or standards
Building collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels
Creating an environment to proactively identify, develop, and implement areas for work process improvement
Supporting a state of readiness for Health Authority, internal and divisional audits as needed
Ensuring implementation and maintenance of safety standards as relevant for the team
**Requirements**:
Master’s Degree in natural Sciences (biology, chemistry, pharmacy) or related field and proven experience in the pharmaceutical, biotech or another regulated industry
Experienced people manager with ability to coach experts
Ability to conduct multiple investigations within established deadlines
Qualified Person certificate is a plus
Experience in drug product filling and inspection practices
Quality Risk Management & Project Management preferred
Electronic validation, electronic batch records
SAP-, Trackwise
- and/or Reliance
- knowledge is advantage
Hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools preferred
Ideally having understanding of Critical Process Parameters, Critical Quality Attributes and validation is an advantage
Fluent in English and German
We offer an attractive salary, outstanding social benefits (such as home-office-policy, staff restaurant, free vaccines, annual pass for public transport etc.) and an exciting leadership role in an international environment. The minimum annual salary for this position is EUR 80.000;
Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.
Search Firm Representatives Please Read Carefully
**Employee Status**:
Regular
**Relocation**:
No relocation
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)*
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