Director, QA Operations (Quality Events and Data Analytics)

Key Responsibilities

• Manage the QA team responsible for the review and approval of Deviation, CAPA, OOS and Complaints.
• Responsible for execution, oversight, and continuous improvement of quality event processes within QA Operations.
• Establish quality standards for deviations (investigation, root cause analysis, impact, CAPAs, and effectiveness).
• Ensure that event records are completed on time with robust output commensurate with the complexity of the event and meet cGMP expectations.
• Develop KPIs and perform detailed analytical trending of quality events individually and as a collective.
• Present analytics to governance meetings; proactively identify and implement improvement measures based on the analysis.
• Identify, design, champion and implement process improvements using Operational Excellence tools to analyze current state and create future state.
• Work cross functionally with Operations leadership to identify and implement robust preventive actions to minimize the rate of controllable quality events and ensure an effective quality management system.
• Partner with, but do not own, centralized Quality Systems functions.
• Utilize 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.
• Independently formulate solutions to complex problems with little guidance or oversight required.
• Strong problem solving and communication skills.
• Manage/direct the selection, training, motivation, development, appraisal and work assignments of Quality personnel.

Minimum Qualifications

• B.A. or B.S. degree (preferably in Life Science) is required with at least 7 - 10 years of experience in the pharmaceutical or biopharmaceutical industry.
• Sound knowledge of cGMPs and a basic knowledge of biologics manufacturing.
• The ability to interpret and relate Quality standards for implementation is essential along with the ability to make sound decisions that align with cGMPs.
• Able to communicate clearly and professionally both in writing and verbally.
• Flexibility in problem solving, providing direction and work hours to meet business objectives is essential.

Preferred Qualifications

• Six Sigma Black Belt and 3+ years Operational Excellence experience.

Competencies

• Analytical - Synthesizes complex or diverse information; Collects and analyzes information skillfully; Designs workflows and procedures. Generates creative solutions.
• 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 continually build knowledge and skills; Shares expertise with others.
• 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.
• Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
• Visionary Leadership - Displays passion and optimism; Inspires respect and trust; Mobilizes others to fulfill the vision; Provides vision and inspiration to peers and subordinates.
• Change Management - Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results.
• 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.
• 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.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness; Applies feedback to improve performance; Monitors own work to ensure quality.
• Business Acumen - Understands business implications of decisions; Displays orientation to profitability; Demonstrates knowledge of market and competition; Aligns work with strategic goals.
• Cost Consciousness - Works within approved budget; Develops and implements cost saving measures; Contributes to profits and revenue; Conserves organizational resources.
• Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce.
• Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
• Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses; Adapts strategy to changing conditions.
• Judgement - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.
• Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
• Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; 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; Determines appropriate action beyond guidelines; 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.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
• Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• 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.