In this role you will proactively lead, and drive the execution of the quality assurance strategy across the site by overseeing the elements of quality operations, quality control and quality system functions. The position is a key and active member of the Site Leadership Team and interacts with the team to ensure business objectives are aligned and that the company is performing to operational objectives.
location: Tempe, Arizona
job type: Permanent
salary: $145,000 - 155,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
Although much of the work performed in this role impacts the local team, this role also includes the opportunity to provide input into enterprise quality system initiatives which includes but is not limited to the quality system initiatives which possess global impact.
- Reporting to the Sr. Director, Quality Assurance, the role will play a critical part in the company's business planning / strategy development.
- As a member of the Site Leadership Team, deeply engages and effectively contributes to the achievement of site objectives by playing an active role in the strategic planning processes
- Directs and leads the Quality function for combination medicinal products, investigational medicinal products (IMP) and medical device products and components molded, assembled, and packed to meet and exceed all regulatory requirements, customer requirements and key performance indicators.
- The role will also have a dotted line reporting relationship to the Director, Operations, Arizona to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same.
- In accordance with US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/ Official Correspondent on all government agency issued authorizations, communications and registrations.
- Leads, develops, and executes on the local quality strategy for the campus, ensuring alignment to the global vision and strategy and defining quality objectives in line with overall Contract Manufacturing quality objectives.
- Cultivate a positive working relationship with the Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West's product quality and reliability meets or exceeds customers' expectations.
- QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.
- Direct and oversee the Quality Assurance, Quality Engineering, Quality Systems and Quality Program teams. The role will lead the engagement and interaction with key internal customers specifically Program Management, Operations, Engineering and Continuous Improvement teams and will be first point of contact for key strategic external customers.
- Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines
- Manage the customer satisfaction processes and lead improvements of overall customer satisfaction if discrepancies are identified.
- Directs in line with Sister Site agreement requirements for products manufactured at other sites.
- Leads regulatory agency interaction related to compliance to local and regional guidelines/ regulations and develops strong internal and external relationships with regulatory bodies and authorities
- Establish, monitors, and provides weekly / monthly progress of the Quality KPIs and communicate it to the organization and senior management.
- Responsible and accountable for quality departmental budget
- Accountable for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies and combination products.
- As the management representative , ensures the quality system is implemented and its integrity maintained
- Direct and leads the facility readiness for all third part audits including notified bodies.
- Leads alignment and standardization of best practices and enterprise excellence across all sites producing Customer or Company owned platform devices.
- Play a role as a key contributor to Global Enterprise Quality documentation updating, including where appropriate, leading any updates
- Inspires innovation and quality excellence ensuring this culture is deeply engrained and sustained in the organization DNA
- Leads by example and sets the highest standards in employee engagement and communication.
- Is a champion for talent development (personal and team) ensuring commitment to local and global programs.
- Other duties as assigned based on business needs
qualifications:
- Bachelor's Degree in either pharmacy, chemistry, biology or equivalent.
- Significant experience (10+ years) in medical device/pharmaceutical manufacturing, quality assurance, regulatory affairs, or a related field.
- Experience in regulatory compliance management, including familiarity with FDA and other regulatory agency requirements.
- Proven track record of implementing process improvements and ensuring compliance with regulatory standards.
- Regulatory Skills: In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH guidelines, and other relevant regulatory requirements.
- Leadership Skills: Strong leadership and management skills with the ability to lead cross-functional teams, drive initiatives, and influence stakeholders at all levels of the organization.
- Communication Skills: Excellent communication skills, both written and verbal, with the ability to effectively communicate requirements and strategies to diverse audiences.
- Analytical Skills: Strong analytical and problem-solving skills, with the ability to analyze complex problems, identify root causes, and develop effective solutions.
- Adaptability: Flexibility and adaptability to navigate changing regulatory landscapes and business priorities.
- Ethical Standards: Adherence to ethical standards and integrity in dealing with regulatory agencies, colleagues, and stakeholders.
- Self-motivated with a proactive attitude and the ability to work effectively.
skills: FDA, Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
