- Lead and manage the Quality Operations teams responsible for batch record creation/review, product release, deviation management, change controls, and customer interactions.
- Develop, establish, and maintain quality assurance programs, systems, and controls to ensure compliance with regulatory standards, including FDA, EMA, and other relevant agencies.
- Interact with customers and regulatory agencies to ensure alignment with regulatory requirements and customer expectations.
- Oversee the management of label room personnel and deviation management processes.
- Collaborate with internal teams (Business Unit, Operations, Engineering) to achieve company goals and objectives.
- Ensure the Quality Operations team achieves appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPIs.
- Establish policy throughout the commercial manufacturing enterprise for adherence to FDA, EMA, ANVISA, and all other relevant government agencies.
- Provide management over the Quality Business Unit teams.
- Responsible for Deviation Management processes.
- Partner with internal teams (Business Unit, Operations, Engineering) to achieve company goals.
- Bachelor's or Master's degree in a relevant life-science field.
- Minimum of 5+ years of operational quality and manufacturing experience in pharmaceutical or biotech industries.
- Proven leadership experience in managing Quality teams with product release responsibilities.
- Experience in managing drug/device combination products, preferably with expertise in auto-injection technologies.
- Strong understanding of regulatory requirements for pharmaceutical and biotech products, including FDA, EMA, etc.
- Excellent communication skills with the ability to interact effectively with internal and external stakeholders.
- Prior experience in managing contract service providers or working in a contract manufacturing or contract packaging environment is advantageous.
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Director Quality Operations
5 days ago
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Director Quality Operations
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PCI Pharma Services Philadelphia, United StatesSUMMARY: · The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad ...
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Director, Quality Operations - Philadelphia, United States - Global Life Science Hub
Description
Job Description
Job DescriptionGlobal Life Science Hub is proud to announce an exciting partnership with a leading global trailblazer who is revolutionizing pharmaceutical excellence with integrated services spanning from drug development to commercialization. With ambitious plans to expand their Pennsylvania site by 3x fold this year, were excited to be leading a search for a brand-new Director of Site Quality Operations.
The Director of Quality Operations will play a pivotal role in ensuring the quality, compliance and expansion of operations at the Philadelphia site. This position requires a dynamic leader with extensive experience in quality management, particularly in drug/device combination products, preferably with expertise in auto-injection devices.
Position: Director, Quality Operations - Philadelphia
Responsibilities:
Experience/Qualifications:
Apply:
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you're interested, please apply below. If this position doesn't interest you, please visit our website for a list of more vacancies –
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