Director I / II, Quality

Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!

Join our mission at Adare!

What can Adare offer you?

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs

We are seeking to hire a Director I or II Quality to be a valued leader in our Quality team…

If any of the below describes you, we would love to meet you!

Summary

The Director of Quality – Orthodox Street facility is a member of the Adare Pharma Solutions quality leadership team, and will oversee all Quality operations and teams for the Orthodox Street facility in Philadelphia PA, assuring compliance with all applicable GxP regulations in the markets required by our clients (i.e. FDA, EU, ANVISA). This Director will provide direction, leadership and development to the Quality Assurance/Control and Operations staff in Philadelphia, and will develop, maintain and continuously improve the Quality System to assure conformance with all GXP’s and regulatory requirements.

Responsibilities

• Serve as the site head of Quality for the Orthodox Street facility
• Assure cGMP and regulatory compliance with all FDA and applicable external US regulatory requirements and guidance documents within Adare and its vendors.
• Direct and assure all Adare Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.
• Produces value-added results through effective recruitment, delegation, performance management, training and development of employees.
• Manage all FDA and other regulatory agency activities including facility inspections, inquiries, notifications, all and other agency associated activities.
• Set and maintain appropriate policies and procedures to maintain regulatory compliance.
• Direct the management of customer and regulatory audits of the facility.
• Maintain quality systems for use at Adare to ensure production of quality product and all of its related activities (e.g. Facilities & Engineering, Production, Quality Control).
• Ensure compliance with cGMP and other relevant Quality System training assignments for Adare-Orthodox Street employees.
• Approve documentation used in relation to production of product and its related activities (validation, engineering, quality control testing, analytical methods and specifications, etc.)
• Manage the following specific activities for the Orthodox Street facility:
• Investigation systems (including “out of specifications”)
• Customer complaints related to bulk drug product manufacturing
• Change control program
• SOP, Batch Record System
• In-process and bulk product specifications
• Provision of quality and production data for drug product applications
• Quality Manual preparation
• Material (intermediate and finished bulk)
• Lead the personnel in accordance with Adare philosophies to include performance appraisals, training and development programs, team building, etc.
• Identify resources required for effective and efficient operation of the department.
• Actively participate in the management of the Orthodox Street facility, including the development and implementation of policies.
• Participates in Global Quality team meetings; helps develop global quality policies.
• Actively participate, with other managers, in the identification and resolution of problems related to Adare operations.
• Communicate and provide leadership to staff to obtain good attitude, team effort, productivity, loyalty and quality improvements. Communicate concerns, needs and recommendations to management.
• Provide and assist Regulatory with ANDA, NDA or IND applications as needed.

Requirements

• Bachelor’s Degree with 8+ years’ of industrial leadership experience, with minimum 10 years of Quality experience.
• Experience leading the Quality interface with clients in an FDA/ cGMP environment
• Demonstrable success leading teams; able to sense and manage diverse business cultures - both for integrating into the company and for dealing with partners
• Experience with Quality Management System implementation and integration, preferably on a global scale
• Through knowledge of cGMP, GLP and DEA regulations, NDA and ANDA requirements, Audit procedures
• Expertise in Process and System Validation
• Proven track record of managing complex Quality investigations, managing risk and being results driven and capable of rapid decision making
• Experience leading inspections of regulatory agencies
• Experience with SOD manufacturing and in Quality, Operations or Tech Ops roles
• Demonstrated experience in Organization Design, Lean/Six Sigma application to Quality Operations, and Talent Development
• Experience interfacing with Manufacturing, R&D, Management personnel, customers, outside vendors, suppliers, consultants and government agencies.
• Confidentiality of projects, test results, and both customer and Company information/data is a definite requirement.
• Ability to accommodate up to 20% travel.

Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.

PRINCIPALS ONLY

NO AGENCIES OR THIRD PARTIES

Benefits

• Medical/dental/vision/life – low employee premiums
• 401k with a highly competitive match
• Generous PTO, including floating holidays
• Career growth and internal opportunities
• Tuition reimbursement
• Relocation assistance
• Performance-based bonus
• Employee Recognition Programs