Our Large Global Pharmaceutical Client is looking for a Director of Quality to do the following:
- Ensures corporate compliance to Regulatory Agency requirements (i.e., FDA, EU, DEA, etc.) from a Quality perspective throughout the clients manufacturing plants within his oversight (and to some degree regarding contract manufacturing companies where this position acts as Quality liaison interact for limited third party cGMP oversight).
- Head QA/QC Designee for US Operations within the Corporate CQMS System (i.e., TrackWise®) for all applicable Quality interactions (Deviations, Investigations, CAPA’s, etc.)
- Leads, develops, implements and maintains quality strategies, procedures and systems in line with corporate business goals. Ensures that these quality strategies, procedures and systems and continually improve quality systems and implement corrective actions as appropriate.
- Ensures that products and / or materials are being tested strictly under cGMP conditions and disposition is taken on time as per the committed Production Plan of every month (C to A, > 95%) and / or procedural requirements whilst continually improving to build efficiency into Quality processes to increase productivity.
Management of various Quality resources to ensure compliance while maximizing internal and external customer service.
- Direct various Quality oversights within the US Operations.
- Approve all applicable Methods, SOP’s, Guidances, etc.
- Review and approve contract manufacturer Confidentiality Disclosure Agreements, Quality Agreements, Change Controls and Investigations.
- Lead risk assessment initiatives related to Quality operations.
- Identify and lead initiatives in support of continuing improvement in Quality and Customer Service both internally and externally.
- Participate in vendor and internal audits. Extensively involved in the Corrective And Preventative Action (CAPA) plan of the vendor and self audit program.
- Actively participates in the training of Quality management and staff.
- Interaction with Regulatory Head for filings of ANDA’s and NDA’s.
- Apply knowledge of the most current Regulations to ensure Quality compliance. This at times requires making recommendations to change existing processes, equipment and or systems, sometimes at considerable cost to the company and / or company vendor partner.
- Contract manufacturers, packagers, and vendors - their Heads of Quality and Production.
- Customers - their Heads of Quality (periodic Auditor visits as well).
Experience with various Analytical Instruments, preferably includes but is not limited to the following: HPLC, GC, AA, IR, UV, LD-PSD (Malvern), etc.
- Proficient in all Microsoft applications and knowledge of specialized software applications (SAS / JMP - Statistical, AutoCAD - Architectural, etc.)
- Involved in the selection, configuration and qualification (i.e., IQ/OQ/PQ) of multiple specialized software systems (should possess working knowledge), preferably includes but is not limited to the following: TrackWise (Change Controls, Deviations, Investigations and CAPA), QUMAS and Documentum (Electronic Document Repository), Velquest (Paperless Notebook), Millennium/Empower (Chromatographic Acquisition), Nugenesis (Electronic Data Archival), NovaTek (Stability Tracking & Trending), WDMS and SAP (Supply Chain) and LIMS (Laboratory Information Management System)
- Technical Review & Writing, includes but is not limited to the following: Protocols, Test Methods, Standard Operating Procedures, Corporate Policies, Global Quality Standards, Quality Agreements, Confidentiality Disclosure Agreements, Change Controls, Deviations, Investigations, CAPA’s, responses to Regulatory Agency observations, etc.
- Certified Trainer (First Aid, Methods, Procedures, Policies, etc.)
- Auditor / Inspector (Data and Document Review, Internal and External Inspection, etc.)
- Lean Six Sigma (provided mentoring, training and guidance to Green & Black Belts on multiple (> 25) lean six sigma projects as the Process Owner and / or Project Champion
Conflict Management & Disciplinary skills (knowledge of Human Resources techniques)
- Interpersonal skills (Internal / External interactions, Public Speaking, etc.)
- Planning and Organizing skills
Minimum of BS in Chemistry, Pharmacy, Biochemistry or related field.(MS/PhD preferred
Experience: Minimum of 15 years Management experience in Pharmaceutical companie within the QA/QC environment