Senior Quality Manager responsible for customer advocacy in bioproduction quality assurance. Leading customer-facing activities and driving continuous improvement across divisions.
Responsibilities
Serve as the primary Quality point of contact for assigned strategic and key customers, building strong, trust‑based relationships across all four divisions (BCD, PPA, SUD and FSD).
Lead customer-facing quality discussions, including issue resolution calls, quality reviews, and routine governance meetings.
Ensure timely, clear, and aligned communication to customers regarding quality performance, escalated investigations, and improvement actions.
Represent the Quality organization confidently in customer interactions, escalating risks and opportunities appropriately.
Work with relevant key partners with the implementation of Change Notifications and Quality Agreements for key customers.
Lead and coordinate the resolution of complex customer quality issues, including complaints, deviations, and escalations.
Partner with Site Quality, Operations, Technical, and Commercial teams to ensure investigations, root cause analysis, impact assessments, and CAPAs are robust, timely, and customer‑appropriate.
Contribute and maintain Executive Briefing Documents and customer-facing materials, ensuring accuracy, consistency, and clarity.
Support the development and execution of Quality Improvement Plans (QIPs) for key customers, aligned with broader BPG quality strategy.
Drive standardization of customer advocacy processes, tools, KPIs, and reporting within scope.
Identify opportunities to improve efficiency, consistency, and customer experience through data, digital tools, and best practices.
Requirements
Bachelor’s Degree in Science or related field required
ASQ or similar quality certification (preferred)
Minimum of 7-10 years’ experience in pharmaceutical, bioprocessing, or medical device manufacturing.
Prior experience with product complaints, deviations, CAPA, and root cause analysis.
Demonstrated experience managing complex customer quality issues and escalations within the company and with Customers.
Proven track record of direct customer interaction, including leading calls and issuing written reports.
Knowledge of BPG products and manufacturing processes desirable.
Experience interacting with customers including direct verbal interaction and issuing written reports
Strong written and verbal communication skills, with the ability to translate complex quality topics for varied audiences.
Solid understanding of applicable quality systems and regulations (e.g., FDA, ISO 13485, MDSAP).
Effective project management skills, with the ability to coordinate actions across functions and sites.
Customer‑focused, collaborative, and able to operate confidently in ambiguous or high‑pressure situations.
Ability to demonstrate business insight and drive growth.
Ability to travel up to 25%
Benefits
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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