QC Associate Director

Job Description

Associate Director of QC

Responsibilities

• 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

Qualifications:

• 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.

Skills:

• 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.