Executive Director, Quality Assurance (Onsite)

EXECUTIVE DIRECTOR, QUALITY ASSURANCE (ONSITE)

Partner Therapeutics is a commercial biopharmaceutical company committed to improving the lives of patients with cancer and other serious diseases. Our dedicated team brings a rigorous approach to science, establishes deep partnerships with medical and scientific communities, and works tirelessly to expand potential treatment options and address unmet medical needs.

POSITION SUMMARY

The Executive Director, Quality Assurance role provides leadership and strategic direction of Quality teams responsible for day-to-day Manufacturing Operations, Quality Investigations, Quality Systems, Risk Management and Auditing. This individual will lead efforts to adapt to industry trends, new regulatory requirements, scientific advancements, or competitive pressures and will focus on the "what" and "why" of proposed initiatives, influencing high-level business decisions that affect the function's success. This individual will ensure appropriate compliance oversight of internal and external customers, input into quality-related issues associated with ongoing operations, and identification, development and implementation of continuous improvement initiatives within the department and the wider organization.

PRIMARY RESPONSIBILITIES

Functional:

• Provides QA oversight of the Staff, systems, and procedures governing the cGMP activities at the Northpointe manufacturing facility including Production, Validation, Engineering, Automation, Facilities and Quality Control, as well as all supporting departments.
• Ensures the administration and maintenance of Quality Systems and procedures relating to Deviation/CAPA, Change Control, Training and Document Management programs.
• Responsible for robust investigation / CAPA program (e.g. timeliness, thorough and risk based).
• Responsible for Risk Management and ensuring risk methodologies are embedded in core business processes.
• Ensures External and Internal Auditing program is maintained and aligned with industry and right sized for business, operations and risk.
• Ensures appropriate KPI's/metrics are in place to monitor compliance and proactively develop mitigations/remediations as required.
• Facilitates and leads Site Quality Council to ensure KPI's/metrics are monitored, risks/issues escalated, and remediation established, appropriately.
• Keeps abreast of current industry trends, compliance requirements, and best-of-class technologies relating to area of responsibility through self-education, networking/participating in industry and professional groups. Pro-actively applies learned best practices, knowledge, and benchmarking to PTx projects and solutions.
• Anticipates, identifies, and communicates risks in area of responsibility and across the site; proactively creates strategies and plans to manage risk to the operations.
• Works collaboratively with inter-department and cross-functional teams to lead improvement implementations in a timely, effective, and compliant manner.
• Resolves "stuck" issues by ensuring timely issue escalation to Leadership and cross-functional teams and leads the creation of new/updated systems, processes, programs to prevent similar situations in the future.
• Pursues collateral duties as they become available to support personal growth, connection, and skill development.
• Adheres to all applicable regulations and requirements including compliance with internal SOPs, GMP, Health and
• Safety, WISHA/OSHA, regulatory compliance, company policies, and employment-related laws and statutes.

People Leadership:

• Establishes department and individual goals in alignment with site goals and priorities. Ensures capabilities and capacity are in place to effectively deliver on all departmental commitments and performance targets.
• Builds, develops, inspires, motivates, and leads a diverse, professional team. Sustains high performance that is strongly aligned and coordinated with other functional groups across the organization; ensures Partner engagement by creating a culture of inclusion, execution, and an environment within which they can excel and continuously develop.
• Manages and develops the performance of direct reports by setting clear SMART goals, provides and seeks timely performance feedback, recognizes and rewards high achievers, and holds team members accountable for underperformance. Leads by example and promotes PTx's core Values: Learn, Prepare, Innovate, Collaborate, Lead to continually improve the Quality Culture at PTx.
• Meets consistently with all Direct Reports in the current PTx format and as a team to ensure 2-way updates, conversations, and alignment on goals and priorities are clear and reinforced regularly.
• Through active leadership and coaching, while embracing PTx's Values and Behaviors, holds Team accountable for compliance to all safety and quality regulations, ensures all team members directly or indirectly support cGMP activities, have the necessary education, knowledge, and skills to perform their job in accordance with applicable procedures and regulations.
• This job description is not intended to be all-inclusive. Partners may be required to perform other related duties as required to meet the ongoing needs of the organization.

KNOWLEDGE, SKILLS, ABILITIES

Required:

• Comprehensive knowledge of FDA and non-USA regulations (e.g. PMDA, EMA) and experience in inspections/response writing, of the biopharmaceutical industry.
• Proven ability to lead Quality teams and strong critical thinking, analytical, and problem-solving skills with the proven ability to formulate strategic solutions to propel the organization forward.
• Resourceful with proven ability to lead, manage and leverage an extensive internal network of stakeholders, team members, and external resources to plan and resolve issues.
• Strong, collaborative relationship management and interpersonal skills required to quickly gain confidence of stakeholders and team members.
• Possesses strong organizational and prioritization skills to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget, experience with the principals of operational excellence. Demonstrated ability to delegate successfully.
• Strong written and oral English communication skills are required for this highly collaborative role. Proven ability to make clear, effective, and persuasive presentations to audiences at various levels of expertise required. Skilled at leading effective meetings.

Preferred:

• Formal project management training and/or certification.
• Detailed knowledge of Quality Management Systems ("QMS") and use in electronic platforms required. Deep operational, developmental, and compliance QA knowledge including recent application of this knowledge and associated skills in a cGMP manufacturing environment.
• Software application experience with Smartsheet, MS Project, and SharePoint.

PEOPLE LEADERSHIP QUALIFICATIONS

Required:

• Demonstrated commitment to fostering the professional growth and development of others.
• Strong leadership skills and proven ability to drive accountability and build a departmental culture of trust, compliance, efficiency, and continuous improvement.
• Skilled at active listening, conflict resolution, and team building.
• Significant experience working collaboratively with HR/People & Culture functions to recruit, hire, grow, and retain talent. Proficiency in standard recruiting and hiring protocols; recent, practical experience with the hiring processes as both a hiring manager and interviewer.

Preferred:

• Formal people leadership training; advanced coaching and giving-and-receiving-feedback skills.
• Formal interview training.

EXPERIENCE & EDUCATION

Required:

• Bachelor's Degree or equivalent if obtained outside the U.S.; Biology/Chemistry/Biochemistry/Microbiology.
• 12+ years of progressively responsible experience in the life sciences industry required.
• 8+ years of People Leadership experience. People Leadership qualification includes experience in recruiting, making hiring decisions, setting SMART Goals, growing high performers, coaching, and addressing performance concerns.

Preferred:

• Advanced degree a plus; MS, MBA, etc.
• 10+ years of QC and/or laboratory experience in a cGMP Manufacturing Environment or equivalent.

PTx is committed to the principles of competitive and pay equity for all of our Partners. The current pay range for this position is $259,000 - $295,000: Offers are made within the base pay range applicable at the time. Your salary will vary depending on several factors including your qualifications and experience.

In addition to medical, dental, vision, FSA/DCA, HRA, disability, and life insurance coverage, all full-time, regular Partners enjoy a casual, and Hybrid or Remote workplace program for many roles. We offer a terrific compensation/benefits/perks package which includes pre-IPO options, annual cash bonuses, 401k matching, free parking or Seattle-area ORCA pass, tuition assistance, plus rewards for achievement and contribution. To support a healthy work-life balance we also provide a gym subsidy, wellness participation programs, and a generous vacation, sick, and holiday paid time off program in addition to a paid shutdown between the Christmas and New Year's holidays.

Partner Therapeutics is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, age, national origin, veteran status, marital status, sexual orientation, gender identity, disability or any other category prohibited by local, state, or federal law. This policy applies to all aspects of employment, including recruitment, placement, promotion, transfer, demotion, compensation, benefits, social and recreational activities, and termination.