Manager – External Manufacturing

Manager – External Manufacturing

Requirements

• Earned Bachelor’s degree in a relevant field
• 3+ years (5 preferred) in Operations or Quality with the application of cGMPs in a regulated industry (pharmaceutical industry preferred)
• Excellent oral and written communication skills (particularly in relation to cGMP documentation)
• Project management skills/experience is extremely helpful
• Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience preferred
• Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship
• Excellent team work and negotiation skills in dealing with internal and external partners with the ability to lead and manage quality related projects
• Ability to effectively communicate with all levels of associates within and outside of the organization is essential
• Significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations is highly preferred
• Thorough knowledge of GMP’s and regulatory requirements (including Sarbanes Oxley) would be helpful
• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, API’s, lyophilized and medical drug/device combinations preferred
• Ability to communicate in French is desired but not required

Responsibilities

• Ensures the efficiency of Quality System implemented between Sanofi and the sub­ contractors ensuring a relevant management for complaints, deviations, change controls, non-conformities or any activity aiming to ensure the production, the control and the release of products accordingly with Quality requirements
• Strengthens the Quality and Regulatory strategy particularly during crisis management and verifies the implementation of the relevant action plans
• Support the External Manufacturing North America Audit Program by working with and conducting contractor audits to assure compliance to Sanofi Quality Directives, current Good Manufacturing Practices (cGMPs), and regulatory filings. Leads or participates to the subcontractors audits and manages the CAPAs that follow
• Support projects as assigned such as new product launch teams
• Identify and assist in the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to Sanofi products
• Develops and negotiates the subcontractors Quality Agreements defining the responsibilities between both parties and provides quality advice to subcontractors
• Participates with subcontractors to find solutions concerning quality issues
• Respond to customer complaints, including close out and determination of corrective actions
• Identify and prevent or resolve issues that could impact the continuity of supply of existing products
• Review/Approve sub-contractor’s validation protocols, Master Documents and significant deviations and investigations
• Regular and frequent contact with vendors through formal meeting (systematic business review meeting) or informally when issues can’t wait
• Constant contact with the Senior Director of Quality, regulatory, MSAT and global quality
• Regular contact with Legal to ensure the compliance of the activity to all laws and in preparation of Quality Agreements
• Collaborate with numerous country’s affiliates quality personnel
• Decision making for quality and compliance issues including but not limited to the disposition of product, deviations, change control, qualifications/validation, approval of investigations and assist in the decisions to inform regulatory agencies on issues
• Solve problems by working with quality and technical counterparts at external manufacturing sites as well as the technical/analytical team internally

Preferred Qualifications

• 5 years of experience in Operations or Quality preferred
• Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience preferred
• Significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations is highly preferred
• Thorough knowledge of GMP’s and regulatory requirements (including Sarbanes Oxley) would be helpful
• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, API’s, lyophilized and medical drug/device combinations preferred
• Ability to communicate in French is desired but not required