Job Title: Senior Quality Assurance Manager
Location: WMFTS - USA - Supply - Devens, MA
Location Type: On-Site
Website: https://www.wmfts.com/en/
Group: https://www.spiraxgroup.com/
This role will focus on:The Sr.Quality Manager is a key member of the Senior Leadership Team, responsiblefor creating and driving the site quality strategy, fostering a culture ofquality excellence to deliver high-quality products that meet customer andregulatory expectations. They areresponsible for the Quality Assurance, Quality Control and Supplier Qualityteams within the organization.
This role provides strategicquality leadership and tactical oversight, developing a culture of 'RightFirst Tiime' and driving continuous improvement.
Demonstrating exceptional peopleskills, you will lead, mentor, coach, inspire and empower our talented teamsand individuals to continuously learn, develop and achieve their fullpotential.
Key accountabilities include:Strategic Leadership
- Define, own, and implement the site quality strategy, aligned with the corporate and global quality strategy, and compliance standards.
- Contribute to long-term business planning as part of the senior leadership team. Influencing senior stakeholders to embed quality into decision-making.
- Represent the site during external and customer audits, and customer quality engagements.
- Champion quality leadership and alignment across the site.
- Shape a culture where quality is integral to all operational and strategic decisions.
Quality Execution & Improvement
- Ensure, through embedding quality into all areas of the business, that products meet or exceed customer expectations.
- Monitor and continuously improve quality systems, ensuring compliance with ISO, other applicable standards, and customer quality expectations.
- Drive initiatives to enhance product quality, reduce defects, and improve right-first-time performance
- Drive improvements in supplier quality, in collaboration with the supply chain team, overseeing supplier qualification, audits and ongoing performance monitoring.
- Lead root cause analysis ensuring the implementation of effective corrective and preventive actions (CAPA).
- Ensure product technical transfers are completed compliantly and appropriate oversight and controls are in place for transferred products.
- Working with quality peers across Watson-Marlow,ensure the standardization of quality processes to drive quality improvementslocally and globally
Quality team leadership &development
- Lead and manage the site quality assurance, quality control and supplier quality teams, ensuring clear objectives, performance management and professional development
- Oversee and improve QA activities including batch record review, SOPs, deviation management, change control, CAPA, and product release. Ensure quality and compliance driven decision-making to support uninterrupted operations.
- Oversee and improve QC activities including incoming inspections, in process quality inspections, finished goods releases, and calibration/metrology services.
- Foster a culture of accountability, collaboration, and continuous improvement within the quality function
- Develop succession plans and build capability toensure the development of high-performing teams to meet future business needs.
Compliance oversight
- Maintain site compliance with all relevant regulatory requirements and internal quality standards.
- Ensure site readiness for audits and inspections, providing education and direction in the activities and behaviours required to ensure a successful audit.
- Lead responses to audit findings, ensuring clear and timely communication with auditors.
- Oversee key quality processes, such as, document management, non-conformance & CAPA management, change management, risk management, and validation.Ensuring outputs meet the needs of the business and our customers.
- Define, implement and monitor robust quality KPIs.Using data-driven insights to influence strategic decisions and resource allocation.
Training & Competency
- Develop and implement training programs to ensure appropriate site-wide competency in quality systems and requirements
- Promote quality awareness across the site through engagement and education initiatives
Skills/Experience Required:- Experience of leadership within a medical/life science manufacturing environment
- Demonstratable experience of a site senior leadership role
- Planning and implementation of quality management systems.
- Muli-sector quality systems and standard experience with a particular emphasis on BioPharmaceuticals and Medical Devise. Experience in implementing quality management systems: ISO 9001, ISO 13485 and of GxP legislation and guidance.
- Experience with compliance standards such as: REACH, RoHS.
- Building quality capability.
- Leading and receiving Quality Management system audits.
This position offers a salary range of (USD 116,867.00 - 175,300.00 Salaried). Final salary offers are determined by multiple factors, including education, experience, internal equity, geographic location, and the candidate's expertise, and therefore may vary from the range listed. For roles based outside Massachusetts, the applicable salary range may be lower.
At Watson-Marlow, we believe in taking care of our colleagues. We offer a generous benefits package, including:- Robust Retirement Plan: Benefit from a 5% employer 401K contribution, plus a 50% match on up to 3% of your contributions for added financial security, empowering your financial security.
- Comprehensive and Supportive Parental Leave: Experience our inclusive, gender-neutral parental leave policy, offering 16 weeks at 100% pay. Upon your return, enjoy a gradual transition with a unique 80% work schedule while still receiving 100% of your pay for the first 6 months, ensuring a balanced reintegration into the workplace.
- Generous Time Off: Enjoy ample time off to recharge and attend to life's circumstances with generous vacation and well-being day, 9 observed holidays, 1 floating holiday day, up to 15 caregiver days, and 80 hours of annual sick leave.
- Community Engagement Opportunities: Make a difference with 3 paid volunteer days each year, encouraging you to give back to the community and causes you care about.
- And Many More Benefits: Such as an offering of 3 healthcare plans with HSA contributions along with other benefits designed to support your well-being and professional growth. We invite you to explore all the ways we strive to create a fulfilling and rewarding work environment.
