The posting
SUMMARY/JOB PURPOSE
The Associate QA Operations Director – Systems and Process is accountable for providing QA lead support for Quality Systems (Deviations, Change Control, CAPA, etc.), As a Partner responsible for guiding the organization in the successful, thorough, and timely execution of complex Quality Events (Deviations, Change Requests, CAPA's, CAPA Actions, Change Actions, Effectiveness Checks, etc.). Partners closely with QA and cross-functionally with Pharmaceutical Supply Chain (PSC), Clinical Development/Operations, Information technology (IT), Regulatory Affairs (RA), Global Patient Safety, etc.) as needed to identify, mitigate, escalate, and resolve issues and risks. This role supports development, generation, review, and approval of clinical and commercial artwork and labeling. Demonstrates a high level of independent quality judgment and acumen.
ESSENTIAL DUTIES/RESPONSIBILITIES
- Lead and Partner QA support for Deviations, Change Control, CAPA, CAPA Actions and Effectiveness checks management.
- Provide guidance on Quality systems usage, process requirements, best practices and record completeness.
- Provide QA oversight of Veeva periodic enhancements (quarterly and annually).
- Provide cross-functional guidance on deviations, change requests, CAPA, effectiveness checks and associated actions, supporting complete, thorough and timely completion of the quality records.
- Track and trend supported systems, 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.
- Execute clinical and commercial artwork and labelling review and approval, including oversight of vendors; resolve quality issues. Deliver on company core objectives in a timely manner, per supply plan, and drive for results.
- Lead process and system improvement.
- Responsible for generating a risk-based strategy across the GxP landscape to identify and manage issues and risks while driving continuous improvement, to ensure compliance with global regulatory standards and align with key stakeholders.
- Resolve quality issues, identify and mitigate risk, propose options and solutions, and escalate.
- SME for Health Authority inspections and audits.
- Establish and maintain strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues.
- Foster collaboration within QA and stakeholders, to gain mutual trust, achieve alignment and solve problems.
- Manage conflict by engaging teams to address issues, seeking diverse views and facilitating identification of options to achieve an equitable solution.
- Drive results and influences others outside of direct authority.
- Manage objective setting and balances commitments to prioritize and complete activities within established timelines
- 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 experience.
Experience
- Experience in pharmaceutical or biotech industries, and packaging/labeling 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, blind spots and rapidly escalate cumulative risks
- Demonstrated ability to lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve a goal, and drive for results.
Travel Requirements
- 10% Travel time required for this position.
Environmental Requirements:
- Primarily working indoors in an office environment
#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 - $250,500 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.
