Position Summary: The Senior Director, QA, QC, and Technical Services provides advanced technical and analytical support to Quality Assurance, Technical Services, and the Quality Control Laboratory. This role ensures compliance with cGMP standards, regulatory requirements, root cause analysis, CAPA implementation, and internal procedures while improving the efficiency, accuracy, and compliance of laboratory operations. Responsibilities include troubleshooting analytical and manufacturing processes, leading equipment validations and calibrations, developing and validating chemical assays, mentoring junior staff, and supporting regulatory submissions and inspections.
Roles and Responsibilities:
- Perform technical duties in specialized areas or function as a leader in the absence of management, as assigned.
- Assist laboratory supervisors with tasks as needed.
- Perform efficient and reliable analytical tests following validated procedures for a wide variety of methods and sample types.
- Document all results in accordance with cGMPs and written procedures.
- Troubleshoot and solve problems with assays and equipment with little or no supervision; report all observations.
- Recommend changes to methods and operations as appropriate.
- Interpret analytical results correctly; promptly notify management of analytical or product issues.
- Develop and implement appropriate corrective and preventive actions.
- Lead and write laboratory investigations and support manufacturing plant investigations.
- Participate in analytical method validations or transfers.
- Perform satisfactorily on all analyst qualification studies indicating technical proficiency.
- Plan, perform, and document non-routine tests or special studies under manager's direction.
- Collaborate with QA, QC, and Technical Services teams to ensure timely and compliant manufacturing support.
- Participate in cross-functional projects, investigations, and improvement initiatives.
- Act as technical liaison during interactions with vendors, regulatory inspectors, and internal teams.
- Evaluate and utilize state-of-the-art equipment, including automated and computerized systems, to improve assay performance.
- Maintain and improve proficiency through training; write validation reports, analytical procedures, and SOPs.
- Notify management of SOPs requiring revision and initiate change requests with supporting documentation.
- Conduct special studies per protocols and management direction; prepare well-documented reports.
- Broaden understanding of analytical techniques by reviewing technical literature and attending discussions.
- Provide expertise and mentorship to junior laboratory staff.
- Serve as a technical resource during regulatory inspections and internal audits; conduct internal audits and self-inspections.
- Provide information to external vendors and technical representatives professionally.
- Review and approve analytical results of other lab personnel.
- Calibrate and maintain laboratory equipment per schedule and procedures; document results.
- Lead equipment qualifications by drafting protocols and summary reports.
- Demonstrate mastery of analytical methodology and instrumentation, including MPOWER, LMS, QMS, LIMS, and SAP.
- Support troubleshooting and technical writing related to analytical testing.
- Evaluate and recommend improvements to QA, QC, and Technical Services operations to enhance compliance, efficiency, and cost-effectiveness.
- Create and review technical documents such as change controls, validation protocols, equipment, facility and cleaning reports.
Knowledge, Skills, and Abilities:
- Expertise in chemical, instrumental, and chromatographic analysis.
- Demonstrated mastery of chemist-level skills or specialized technical expertise.
- Advanced computer and troubleshooting skills.
- Thorough understanding of chemical theory and laboratory methodologies.
- Strong leadership and interpersonal skills.
- Excellent verbal and written communication.
- Strong decision-making and prioritization skills.
- Consistent identification of compliance/technical issues with proactive solutions.
- Ability to work independently and in a multidisciplinary team environment.
- In-depth knowledge of cGMPs, FDA, and regulatory agency requirements.
- Ability to manage confidential information appropriately.
Experience Required:
- Minimum 7 to 10 years of analytical experience in the pharmaceutical industry or scientific setting.
- Strong knowledge and experience in cGMPs and regulatory standards beyond QC labs, such as QA compliance.
Preferred Qualifications:
- Master's degree in Chemistry or related scientific field.
- Approximately 7 years of scientific work experience, including specialized skills.
- Previous pharmaceutical industry experience is required.