Responsibilities include, but are not limited to, the following:
• Review and approval of laboratory related GMP documents
- SOPs, Work Practices and associated Forms
- Certificates of Analyses and Reference Standard Purity Statements
- Analytical Protocols and Reports (Development, Validation, Transfer, Stability, etc)
- Methods and Specifications
- Change Requests
- Deviations, Investigations (including OOS/OOTs) and CAPAs.
• Developing policies and procedure based on regulations, industry guidelines and corporate requirements.
• Requires minimal direction to complete tasks; work is self directed and confident in making non-routine decisions in their subject matter area. Consults with supervisor for decisions outside of established processes and manages experienced professional employees.
• Provide Quality oversight of all Metrology & Validation service activities
- SOPs and associated forms
- Validation plans and protocols
- IQ/OQ/PQ documents (equipment and software related)
- User Requirement Specifications
• Assures QA oversight to meet or exceed industry and FDA trends/expectations.
• Generates and maintains Quality Agreements for external GMP testing facilities.
• Implements new policies/systems in keeping with constantly changing/emerging FDA/industry requirements.
• Exhibits excellent leadership and fosters teamwork to create an environment of support that leads to positive motivation and increase productivity of group personnel. Manages conflict and issues with internal and external customers.
• At times, support audits (internal and external) with a quality focus or in partnership with analytical subject matter expert (SME) or as the SME adviser.
• Participate on inter or intra departmental teams as the quality development representative.
• Perform internal and CSP visits to further strengthen quality relationships and optimize our processes.

Qualifications
Skills/Knowledge Required
 GMP and Quality Knowledge: Expert in understanding of cGMPs, Quality and in-depth risk management knowledge.
 Viewed as Subject Matter Expert (SME). Ability to review reports and effectively express Quality risk management principles, policies and procedures. Knowledge of analytical method development and phase appropriate validation procedures for both API and Finished Product would be considered an advantage.
 Communication: Strong verbal and written communication skills are a must. Ability to effectively prepare, with interpretation of data analysis and potential problems, to management and group with clarity and high level of accuracy.
 Technical/Scientific Knowledge: Experienced manager of projects (management of personnel is a plus). Provides guidance to other employees in interpretation of technical/scientific issues across a majority of job functions and manages development of initiatives by interdisciplinary teams. Ability to lead and work within a team setting.
 At least 10% of travel required.

Education and Experience
• Scientific degree BS/MS in pharmaceutical or related science, preferably in Chemistry or Biochemistry.
• Minimum of 7 years experience in R&D or QA discipline with thorough knowledge of GMP activities conducted in an Analytical development laboratory. Minimum of 4 years of leadership experience.