Sr. Manager (Site Quality Head)
- Establish and lead short- and long-term Quality objectives aligned with company goals, PSG & CTD strategy, and site priorities.
- Serve as a member of the site leadership team, actively shaping business strategy while ensuring compliance is never compromised.
- Provide mentorship, coaching, and development opportunities to cultivate a hard-working Quality organization.
- Manage and elevate the site Quality System to align with cGMP, FDA, EMA, and global regulatory standards, ensuring adherence throughout all packaging, labeling, and distribution procedures.
- Oversee qualification, validation, and equipment/premises maintenance while driving a proactive culture of inspection readiness.
- Act as the primary Quality representative during health authority and client inspections, mitigating risks and ensuring successful outcomes.
- Ensure each batch of medicinal product meets applicable legal and regulatory requirements while maintaining transparency with leadership and clients.
- Partner with Operations, Supply Chain, and Client Services to deliver reliable, Right-First-Time execution of packaging and distribution activities.
- Drive a culture of proactive compliance, accountability, and continuous improvement.
- Support business development activities by positioning Quality as a differentiator in client engagements and proposals.
- Bachelor's degree in a scientific or technical field (advanced degree preferred).
- At least 7-8 years of dynamic Quality leadership experience in the pharmaceutical, or medical device industry, including contract manufacturing, packaging, or distribution is required.
- Regulatory Expertise: Extensive understanding of cGMP, FDA, EMA, and other global regulatory requirements, with a track record of effectively coordinating inspections and ensuring compliance.
- Leadership & Influence: 3- 5 years of leadership experience (required) with validated capability in guiding and encouraging dedicated teams, collaborating effectively with diverse partners, and portraying Quality Unit as a dependable partner to clients and regulators.
- Ability to work in an office and manufacturing environment.
- Occasional travel may be required.
- 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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