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Quality Manager in New Castle, DE at Synerfac

Date Posted: 11/4/2018

Job Snapshot

Job Description

Quality Manager:

Quality Manager oversees day-to-day operations of Quality Engineering, Quality Assurance and Quality Control along with the lab; interacts with Regulatory, Supply Chain, Manufacturing and Project Management; and ensures adherence to cGMPs and safety requirements.

Scope of Authority span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

Oversight for QC operations covering raw material, incoming materials and finished manufacturing products with annual sales of approx. $50 M. Position has up to 4 direct reports and approximately 10 in direct reports. Responsible for Quality Control activities, budgets including testing and stability.

Key Accountabilities

Oversee day-to-day operations, coordinating the testing and release of materials in consultation with Planning / QA / Purchasing / Manufacturing / Sales.

CAPA Management

Change Management

Investigation Management

Risk Management Assessment

Recipe Management

Quarantine Disposition

Lab Management

Calibration Management

Product/Vendor Development

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 ensure timely completion of testing, provide data to regulatory groups; conduct data trending.

Oversee qualification of new or alternate source materials.

Ensure adherence to cGMP’s and Safety Requirements.

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, conduct, participate for internal and external 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

May participate in preparation of annual QC budget based on sales forecast, manpower and equipment requirements.

Participate in development, validation and new customer product launches, evaluating requirements for new customer products from a QC and validation perspective.

Qualifications Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job

BS in Chemistry, 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. Knowledge Proficiency in a body of information required for the job, e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

Strong knowledge of FDA regulations.
Strong knowledge of cGMP.
Understanding of OSHA and ISO regulations
Coaching, negotiation, calibration and technical writing

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; 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 Management - 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.

Physical Requirements Physical & mental requirements, e.g. lift 40 pounds, walk across plant/warehouse, some business travel (15% of time), as part of work responsibilities, etc.

Job Requirements

Quality Manager