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SUMMARY/JOB PURPOSE: The Senior Operations QA Manager - Labeling and Quality Systems is accountable for executing assigned tasks, applying Quality tools and metrics to drive continuous improvement across systems and projects. Responsible for end-to-end Quality oversight of GMP Operations. Supports management of Quality Management Systems, artwork and labeling, distribution and temperature excursions . Identifies, mitigates, escalates and resolves issues and risks. Demonstrates high level of independent quality judgment and acumen. Collaborates on improvement projects. The successful candidate maintains or implements harmonization processes across various platforms and creates implementation plans. Supports and guides both the Quality team and stakeholders to assure strategic alignment, including, Production and Supply Chain, Clinical Operations, Legal, and others, as applicable. *This role is onsite five (5) days a week (Monday through Friday). ESSENTIAL DUTIES AND RESPONSIBILITIES:
As QA Core, supports QA Partners. Responsible for maintaining and improving Quality systems and projects, using lean six sigma tools. Executes labeling, systems and distribution activities, and other activities, as applicable. Drives change and drives for results. Works on key projects to close any gaps and supports driving the business forward. Generates or maintains, as applicable, sustainable, robust and lean Quality Systems. Ensures compliance with applicable health authority regulations and guidelines. Tracks and trends systems, provides metrics. Supports audits and inspections. Rapidly resolves any quality issues, identifies and mitigates risk, proposes feasible options and solutions, and escalates without delay. Leads process and system improvements. Interprets and applies Health Authority regulations and guidances across Exelixis' Quality System. Reviews new regulations/guidance's to assure compliance. Supports processes to ensure transition from clinical to commercial product, new product introductions, consistently delivering on targets. Implement innovative and feasible solutions to complex problems. Strong influencer and driver to completion. Strong collaborator and negotiator towards effective solutions. Excellent verbal and written communication and presentation skills. Makes clear recommendations, communicates, escalates and drive timely and effectively.
SUPERVISORY RESPONSIBILITIES:
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:
BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of nine (9) years of related experience; or, MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of 7 (seven) years of related experience; or, Equivalent combination of education/training and experience
Experience/The Ideal for Successful Entry into Job:
Ideally, a minimum of 10 years' of QA experience or the equivalent combination of experience and education/training in biotech, pharmaceutical or related industry Demonstrated knowledge of GxP, Health Authority Regulations, Quality Systems and technical expertise in warehousing/storage and transportation/shipping processes, and product quality decision making. Knowledge of biologics and chemical products preferred. International/global experience preferred. Experience with participation in regulatory inspections and audits, presenting or defending departmental systems and decisions. Understands FDA, EU/ROW regulatory requirements, guidelines, related to storage and shipping validation expectations.
Knowledge/Skills:
Deep knowledge and understanding of clinical and commercial processes, global regulatory requirements and GxP regulations. Demonstrated knowledge and skills in driving company objectives and principles, achieves goals with measurable impact and outcome. Demonstrated ability to apply risk-based approach. Excellent written, verbal and presentation communication skills, able to translate complex concepts across all levels of the organization. Excellent attention to detail, comfortable with ambiguity and complexity. Excellent collaborator demonstrated ability to lead through change and identify opportunities resulting in positive business outcomes. Excellent organizational agility demonstrates obtaining results while strengthening internal and external relationships. Able to influence decision makers, utilizes sound problem solving skills to recommend feasible options and implement effective solutions. Demonstrates strong time-management and organizational ability to analyze and improve processes and consistently produce high quality work. Manages objective setting and balances commitments to prioritize and complete activities within established timelines; works well under tight timelines with right first-time results. Withholds judgement to engage teams in addressing conflict positively, by seeking diverse views and identifying options to achieve an equitable solution. Models team spirit, culture and ethics, drives across cross-functional teams to meet company objectives.
JOB COMPLEXITY:
This role is critical to the success of the clinical and commercial programs and requires continuous communication to maintain alignment across the organization. This role requires management of multiple competing priorities, and the ability to evaluate data to detect weak signals, blind spots and escalate cumulative risks.
WORKING CONDITIONS: This is an onsite position. Travel as required. #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $140,000 - $199,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
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Exelixis
paid holidays, sick time, 401(k)
Nov 06, 2024