Director, QA Operations (Quality Events and Data Analytics)

Description

Your Role:
The Director, QA Operations (Quality Events and Data Analytics) is responsible for leading the execution and oversight of quality event processes (deviations, CAPA, complaints, and OOS) in support of manufacturing operations. This role is part of the QA Operations organization and focuses on real-time quality event management, operational support, and continuous improvement. Responsibility for enterprise Quality Systems (including document control, change control and Quality Risk Management) resides within separate functions.

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. This includes establishing quality standards for deviations (investigation, root cause analysis, impact, CAPAs, and effectiveness); ensuring 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.
• This role partners with, but does 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.
• Occasional overnight travel by land and/or air may be required to attend seminars or conferences or client meetings.
• Other duties may be assigned.

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.
• Must have 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.
• Must be 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.
• Language Skills - Ability to read, analyze and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups and/or boards of directors.
• 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 define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
• Computer Skills - To perform this job successfully, an individual should have proficient personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc. Microsoft Office experience preferred (Excel, Word, PowerPoint).

Preferred Qualifications:

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

Competencies:

• Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; 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 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; Meets commitments.
• 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.
• 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.
• 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.; Continually works to improve supervisory skills.
• Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
• 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.
• 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.
• 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.

Position Type/Expected Hours of Work:

This role is a full-time onsite position. Days and hours of work are Monday through Friday, 8:00am to 5:00pm PST unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.

Compensation:

We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.

The compensation range for this role is $165,600 - $207,000 annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.

Who you are:

• You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
• Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
• You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
• You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.

Physical Demands & Work Environment:

In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.