QC Associate Director
Associate Director of QC
- Oversee day-to-day operations of QC Lab, coordinating the testing and release of materials in consultation with Planning / QA / Purchasing / Manufacturing / Sales.
- Ensure investigations related to testing of materials, reviewing, updating and approval of test methods are done in timely manner.
- Ensure that QC operations complete testing in a timely manner to meet compliance and business needs. Oversee/monitor entire Stability program to ensure timely completion of testing, provide data to regulatory groups; conduct data trending during product shelf life.
- Participate in Change Control, USP/NF articles, review of APR’s and ANDA’s, Analytical and Microbiological Methods transfer and Process Validation projects.
- Oversee qualification of new or alternate source materials, Reduced testing program and alternate testing sites.
- Ensure adherence to cGMP’s and Safety Requirements. Ensure lab area is clean.
- Ensure that data generated by QC operations complies with good documentation practices; oversees personnel and computerized systems to ensure data integrity.
- Interact with regulatory agencies, participate in FDA, consultant and internal QA audits, prepare responses, and implement corrective and preventive actions.
- Continually improve the effectiveness of the QC organization including:
- Upgrading talent through hiring and staff re-alignment.
- Optimizing manpower and instrument utilization.
- Monitoring throughput.
- Mentoring and evaluating staff to develop and
- Streamlining testing in different groups such as AR&D, Planning, QA, Purchasing, Regulatory, Manufacturing, contract manufacturers and vendors in resolving issues.
- May participate in preparation of annual QC budget based on sales forecast, manpower and equipment requirements
- Participate in Development, Validation and New Product Launches, evaluating requirements at Par for new products from a QC and Validation perspective
- BS in Chemistry, Microbiology, Biochemistry or related discipline with 12+ years’ experience in pharmaceutical industry, including 6-8 years of supervisory experience OR
- MS with 10+ years’ experience in pharmaceutical industry, including 3-5 years of supervisory experience OR PhD with 7+ years’ experience in pharmaceutical industry, including 2-4 years of supervisory experience.
- Strong knowledge of FDA regulations.
- Strong knowledge of cGMP.
- Strong knowledge of USP and other compendia and ICH.
- Understanding of OSHA and DEA regulations and laboratory safety procedures
- Analytical - Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data; designs work flows and procedures.
- Problem Solving – Identifies/resolves problems in timely manner; gathers and analyzes info skillfully; develops alternatives; works well in group problem solving; uses reason even with emotional topics.
- Interpersonal Skills - Focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; keeps emotions under control; remains open to others' ideas and tries new things.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
- Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
- Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.
- Managing People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates' activities; is available to staff; provides regular performance feedback; develops subordinates' skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services; continually works to improve supervisory skills.
- Quality Mgt - Looks for ways to improve/promote quality; Demonstrates accuracy and thoroughness.
- Cost Consciousness - Works within approved budget; develops and implements cost-saving measures; contributes to revenue and profits; conserves organizational resources
- Strategic Thinking - Develops strategies to achieve organizational goals; understands organization's strengths & weaknesses; analyzes market and competition; identifies external threats and opportunities; adapts strategy to changing conditions.
- Judgment - Displays willingness to make decisions; exhibits sound, accurate judgment; supports and explains reasons for decisions; includes appropriate people in decision-making; makes timely decisions.
- Planning/Organizing - Prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals/objectives; organizes/schedules people and tasks; develops realistic action plans.