Director, Quality Assurance Operations

Description

Looking to join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals? Avid Bioservices is a leading clinical and commercial biologics CDMO focused on creating innovative solutions to meet the needs of our clients and improve patient outcomes.

Your Role:

The Director, Quality Assurance (QA) Operations will provide leadership and problem solving skills to drive strategic quality related initiatives. This role's responsibilities are to serve as the architect and owner for quality enhancements while maintaining high standards of compliance. The Director will partner cross functionally with leaders and subject matter experts to successfully develop, implement, and champion the initiatives.

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
• Using 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
• Perform other duties as assigned.
• Supervisory Responsibility: Directs activities of functional areas for direct reports.
• Occasional overnight travel by land and/or air may be required to attend seminars or conferences.

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.; Continually works to improve supervisory skills.
• 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.
• Oral/Written Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Participates in meetings. Writes clearly and informatively; Edits work for spelling and grammar; Presents numerical data effectively; Able to read and interpret written information.
• 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.
• Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values; Supports affirmative action and respects diversity.
• 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.
• Planning/Organizing - Prioritizes work tasks; Uses time efficiently; Sets goals and objectives; 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; 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.
• Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; 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; 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. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• 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.

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.