The posting
SUMMARY/JOB PURPOSE
The Associate QA Systems and Process QMS Director is the QA lead accountable for providing organizational guidance, support and act as business owner for Quality Management Systems (QMS), to ensure a fit-for-purpose, compliant and timely execution of complex Quality Events (Change Requests, Change Actions, Deviations, CAPAs, Effectiveness Checks, Issue Escalations, etc.). This role owns continuous QMS improvement by leading process enhancements, delivering training, reporting metrics, and serving as the system Business Owner.
The Associate QA Systems and Process QMS Director partners closely with QA and cross-functional teams (Pharmaceutical Supply Chain (PSC), Clinical Development/Operations, Information technology (IT), Regulatory Affairs (RA), Global Patient Safety, etc.) to identify, escalate, and effectively mitigate issues and risks.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Champion and Partner QA support for QMS (Deviations, Change Control, CAPA, CAPA Actions, Effectiveness checks, etc.).
- Owns business process for eQMS.
- Provide guidance on QMS use, process requirements, best practices and record completeness.
- Provide QA oversight of Veeva periodic enhancements.
- As a Change Control Process owner and QMS Business owner, drive cross-functional compliance, provide QMS guidance, ensure complete, thorough and timely completion of quality records.
- Own governing procedures and drive continuous improvement to ensure fit-for-purpose, risk based QMS processes.
- Track and trend QMS, provide metrics for Quality Systems Management Review (QSMR).
- Provide monthly Veeva Quality event status reports to QA and functional areas, proactively driving timely record closure.
- Develop and chamption a risk-based strategy across the GxP landscape to identify, manage, and mitigate risks; address potential blind spots; escalate issues; propose solutions; drive continuous improvement; and ensure alignment with key stakeholders and global regulatory standards.
- Own continuous improvements of the eQMS platform and Computer System Validation (CSV) processes to enhance efficiency, compliance, and overall system effectiveness.
- Resolve quality issues, identify and mitigate risk, propose options and solutions, and escalate as needed.
- Serve as the SME for health authority inspections and audits, while fostering strong relationships with internal and external stakeholders to ensure timely documentation, escalation, and resolution of quality issues.
- Manage conflict by actively engaging teams to address issues, seeking diverse views and facilitate identification of options to achieve an equitable solution.
- Drive results and influence others outside of direct authority.
- Manage objective setting and balance commitments to prioritize and complete activities within established timelines.
- Serve as backup to other QMS QA leads and support CSV and Data Integrity (DI) QA activities as needed.
- Performs other duties as assigned
- Complies with all policies and standards
SUPERVISORY RESPONSIBILITIES
- No supervisory responsibilities.
EDUCATION/EXPERIENCE/KNOWLEDGE/SKILLS & ABILITIES
Education
- BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or
- MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or
- Equivalent combination of education and applicable experience.
Experience
- Experience in pharmaceutical or biotech industries, and Quality Systems is preferred.
- Experience in development of business strategies, metrics, and continuous improvements is preferred.
- Proven indirect organizational and management skills, ability to manage complex issues, sound decision making and strategic skills.
- Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and manufacturing processes.
- International/global regulatory requirements experience preferred.
- Experience with participation in regulatory inspections and audits, presenting or defending functions.
Knowledge, Skills and Abilities
Required:
- Apply wide range of knowledge of biotechnology/pharmaceutical sector to perform complex work, provides input beyond the QA function and proposes solutions to highly complex issues.
- Understands technical information related to equipment, processes, and regulatory expectations.
- Demonstrate strong time-management and organizational ability to analyze and improve processes and consistently produce high quality work.
- Excellent written, verbal and presentation communication skills, able to translate and communicate complex concepts across all levels of the organization.
- Proven ability to manage multiple competing priorities, evaluate data to detect weak signals, and escalate cumulative risks.
- Demonstrated ability to lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve goals and drive results.
Travel Requirements
- 10% This position requires up to 10% travel.
#LI-HG1
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $176,000 - $251,000 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.
If you have a disability and need an accommodation in relation to the recruiting process, please email us at: [email protected].
WORKING CONDITIONS:
Our office is a modern space that fosters collaboration and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace.
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.
