Sr. Manager, Quality Compliance jobs in United States
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Ferring Pharmaceuticals · 17 hours ago

Sr. Manager, Quality Compliance

Ferring Pharmaceuticals is a privately-owned biopharmaceutical company that pioneers life-changing therapies. The Senior Manager, Quality Compliance will play a critical role in safeguarding product integrity and patient safety by leading compliance initiatives and ensuring adherence to regulatory standards.

BiotechnologyManufacturingPharmaceutical

Responsibilities

Lead with Impact: Drive internal audit programs, inspection readiness, and compliance initiatives that shape our quality culture
Be a Trusted Expert: Provide guidance on GMP, GDP, DSCSA, and FDA expectations to cross-functional teams
Own Compliance Strategy: Develop and refine SOPs, policies, and quality documentation to meet evolving regulatory requirements
Analyze & Improve: Monitor Quality Compliance KPIs, identify trends, and implement continuous improvement strategies
Champion Regulatory Excellence: Host and support FDA and third-party inspections, ensuring flawless execution
Manage Critical Processes: Oversee U.S. recall activities, FAR, BPDR, and FDA communications
Collaborate for Success: Partner with teams on DSCSA compliance, serialization, and suspect product investigations

Qualification

GMP knowledgeFDA regulationsAuditing experienceDSCSA complianceQuality documentationContinuous improvementEthics & IntegrityCollaborationCommunication

Required

Bachelor's degree in Life Sciences, Pharmaceutical Sciences, or related field
Minimum 4 years in pharmaceutical or biopharmaceutical Quality, Compliance, Regulatory or related roles
Strong knowledge of GMP, GDP, GVP, DSCSA, and FDA regulations; proven auditing experience (ASQ CQA, ISO Lead Auditor, Veeva, Trackwise or equivalent), Microsoft Suite knowledge
Ability to influence without authority, manage complex compliance processes, and travel up to 20%

Preferred

GVP auditing experience

Benefits

Comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees
A 401k plan and company match
Short and long-term disability coverage
Basic life insurance
Wellness benefits
Reimbursement for certain tuition expenses
Sick time frontloaded yearly of 40 hours, or higher if state or local law requires
Vacation time for full time employees to accrue between 112.5 and 150 hours yearly in the first four (4) years of employment, and additional accruals starting in the fifth (5th) year of employment
12 to 13 paid holidays per year
Paid parental leave subject to a minimum period of employment at Ferring

Company

Ferring Pharmaceuticals

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Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives.

Funding

Current Stage
Late Stage
Total Funding
$530.88M
2023-03-17Debt Financing· $530.88M

Leadership Team

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Valerio Trifoni
Senior Vice President Group Controlling
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Company data provided by crunchbase