Sr. Director, Manufacturing & Distribution QA

Proclinical is seeking a Senior Director of Manufacturing and Distribution QA for a leading pharmaceutical company located in Wilmington, DE. This position will lead and manage the client's Global Manufacturing and Distribution QA organization and provide strategic leadership across the Technical Operations product portfolio for Quality and compliance to Incyte and regulatory standards.

Job responsibilities:

• Lead and develop the company Global Manufacturing & Distribution QA Operations group
• Develop the functional objectives in line with the business
• Implementation and management of an effective Quality oversight of the company global product manufacturing, supply and distribution operations, including management of associated changes, deviations, complaints as well as the planning of disposition and regional QP certification activities
• Ensure Product disposition is performed in line with procedures and business timelines for supply continuity.
• Ensure internal and external serious quality issues are driven to resolution
• Responsible for informing Senior/Executive management of compliance or quality risks and concerns.
• Represent QA function for introduction of new manufacturing and distribution business initiatives including due diligence activities
• Lead QA Operations in support of new product launches and new markets
• Develop and implement the risk-based vendor Quality management program for Technical Operations and ensure maintenance of Quality agreements with suppliers
• Ensure GMP/GDP audit programs are developed, implemented, and monitored.
• Oversee Product Recall Operations
• Define key Technical Operations Quality metrics and perform periodic GMP/GDP Quality Management Reviews
• Ensure implementation of new regulations and requirements across technical operations as applicable,
• Performs all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements
• Point of contact with Health Authorities for Quality matters in collaboration with RA
• Initiate and implement continuous quality improvement programs
• Ensure Quality risk management principles are applied within technical operations.

Skills and Requirements:

• Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);
• Firsthand experience of min 15 years in Quality Assurance for international pharmaceutical and/or biotech industry with at least 7 years in leadership global roles.
• Thorough knowledge in US, EU, ICH GMP and global regulatory requirements.
• Experience in managing manufacturing and distribution contractors
• International exposure in positions interacting with and influencing sites operations.
• Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements.
• Ability to self-manage and work effectively with internal & external stakeholders
• Ability to identify, prioritize, and implement Quality strategies to continuously improve operations and systems and manage risks.
• Must be a strong leader with the ability to work effectively in a global and fast paced environment while leading multiple projects
• Strong Interpersonal skills.
• Strong verbal and written communication skills with well-structured communication and presentation ability.
• English fluency written and spoken (the company language).
• Knowledge of other languages such as French is an asset.
• Results focused which may require negotiating skills, empathy, diplomacy, common sense.
• Ability to travel domestically and internationally.

If you are having difficulty in applying or if you have any questions, please contact Jason Lawrence at (+1) 646-779-7968 or j.lawrence@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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