This is a rare opportunity to join a young, exciting highly ambitious pharmaceutical company.
Our client is a specialty pharmaceutical company focused on providing therapies to patients with rare diseases. Their seasoned management team has a broad range of experience in commercialization, acquisition, licensing, formulation and product development.
This is a newly created senior management role that requires a highly-skilled individual who is passionate, ethical, team-oriented, excited to be part of a new and dynamic growth opportunity and who wants to help build a company that will make a difference in people?s lives.
As the Quality Team Leader, the successful candidate will be responsible for the establishment and operation of their Quality Management Systems, overseeing the review and approval of products for commercial distribution, providing compliance guidance to key management stakeholders, and developing global standards for the assurance of Good Manufacturing and Good Distribution Practices management consistent with regulatory requirements and company activities and goals. Additional systems will be developed to support future product/development project candidates, as required.
? Establish, operationalize and maintain the global Quality Management System (QMS), to include Product Complaints, Deviation & CAPA, Out-of-Specification Investigations, Root cause analysis, Change Control, Product release for distribution, Internal Audit, SOPs and Controlled Documents, and Systems related training.
- Communicating with internal and external parties to resolve quality issues in order to enable product release and disposition.
- Company-wide preparedness for Regulatory Authority inspections; maintaining high standards of quality.
- Lead Quality interface with strategic business partners relative to commercial and development product candidates
? Engagement with third party contractors and service providers, participating in vendor identification, selection, vendor audits and management, establish/maintain Quality Technical Agreements, all in compliance with QMS and Regulatory requirements.
? Aid in the identification, selection, and management of additional Quality team members.
? Support the diligence review processes associated with new product acquisition(s).
? Identification of key quality trends, periodic reports review and awareness for the management team to insure proactive maintenance of high quality standards and status of compliance.
?Minimum Bachelor?s degree, preferably in Chemistry and/or Pharmacy (or related technical/science discipline); advanced degree a plus.
?Qualified Person expertise.
?Significant experience (15 + years) working in pharmaceutical finished product manufacturing with experience in compliance, quality assurance, and quality control.
?Thorough understanding of quality systems, cGMPs, GDPs, and related GXP systems.
?A minimum of five years of supervisory/management experience, managing a quality team.
?Medical device experience in addition to pharmaceuticals is preferred.
?Experience leading GMP audits, including drug substance, drug product manufacturing and analytical testing sites.
?Experience with sterile/parenteral dosage forms is preferred.
?Process/ product validation and IT compliance experience.
?Experience in defending processes, procedures and investigation during regulatory inspections/audits.
?In-depth knowledge of global Quality System Regulations.
- Ability to interpret, communicate, and apply regulations and compliance concepts
- Excellent communication skills (written and oral)
- Ability to respond to audiences appropriately
- Strong interpersonal skills, interacting easily across organizational/functional levels
- Flexible and adaptable to take on additional responsibilities and deal with change
- Ability to travel; anticipate approx. 25% including US travel.
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