Director, Quality Assurance Operations

Key Responsibilities

• Serve as the Quality representative on cross-functional and multi-site teams.
• Train personnel on relevant business processes and operational excellence principles.
• Identify, design, champion, and implement process improvements using Operational Excellence tools (e.g. Six Sigma, Lean) to analyze current state and create future state.
• Analyze data, generate procedures, training materials, and other documents as appropriate to meet project stage gate deliverables.
• Solve a wide range of difficult issues that impact multiple functions, following cGMP regulations and company standards.
• Utilize regulatory intelligence and industry guidance to provide forward thinking guidance to continuous improvement initiatives.
• Use technical and quality knowledge to provide QA oversight and guidance to real-time Manufacturing floor events resulting in rapid remediation and compliance to client and regulatory expectations.
• Communicate clearly with clients to support issue resolution and client relations.
• Guide teams through systems transitions to support effective “right first time” roll out.
• Independently formulate solutions to complex problems with little guidance or oversight required.
• Strong problem solving and communication skills.

Competencies

• 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; Makes self 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.
• Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
• Analytical/Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
• Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
• Customer Service - Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance.
• Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas; Fosters quality focus in others.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Contributes to building a positive team spirit; Puts success of team above own interests.
• Cost Consciousness - Works within approved budget; Contributes to profits and revenue; Conserves organizational resources.
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Promotes a harassment-free environment.
• Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Follows through on commitments.
• Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
• Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
• Safety and Security - Observes safety and security procedures; Reports potentially unsafe conditions; Uses equipment and materials properly.
• Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
• Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Innovation - Meets challenges with resourcefulness; Generates suggestions for improving work.

Minimum Qualifications

• B.A. or B.S. degree (preferably in Life Science)
• 10+ years’ experience in the pharmaceutical or biotechnology industry, or an equivalent combination of education and experience, with five years in quality assurance.
• Sound knowledge of cGMPs and equivalent regulations.
• Ability to communicate clearly and professionally both in writing and verbally.
• Language Skills - Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Mathematical Skills - Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Reasoning Ability - Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Computer Skills - Proficient personal computer skills, including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc. Microsoft Office – Word, Excel, PowerPoint and Outlook preferred. Should also have working knowledge of Microsoft Project.

Preferred Qualifications

• Minimum of three years of supervisory/management experience.
• Six Sigma Black Belt Certification and 3+ years Operational Excellence experience.