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Senior Manager, Quality Compliance
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Quality Compliance information
See salary details
$31.5K - $32.7K
3% of jobs
$32.7K - $34K
10% of jobs
$34K - $35.2K
8% of jobs
$35.7K is the 25th percentile. Wages below this are outliers.
$35.2K - $36.4K
8% of jobs
$36.4K - $37.6K
12% of jobs
The median wage is $38.8K / yr.
$37.6K - $38.9K
8% of jobs
$38.9K - $40.1K
12% of jobs
$40.1K - $41.3K
8% of jobs
$41.9K is the 75th percentile. Wages above this are outliers.
$41.3K - $42.5K
8% of jobs
$42.5K - $43.8K
12% of jobs
$43.8K - $45K
8% of jobs
$31.5K
$38.6K
$45K
How much do quality compliance jobs pay per year?
What does a quality compliance do?
A professional in Quality Compliance is responsible for monitoring operations to ensure adherence to regulatory standards, conducting internal audits, and updating company policies as needed. They collaborate closely with different departments to address compliance issues, provide training on quality standards, and document findings or corrective actions. Daily tasks also often involve reviewing documentation, preparing compliance reports, and responding to external auditors or regulatory agencies. This role is dynamic and requires proactive engagement to help the organization maintain certifications and avoid potential risks.
What is a quality compliance?
A Quality Compliance job ensures that a company adheres to industry regulations, internal policies, and quality standards. Professionals in this role monitor processes, conduct audits, and implement corrective actions to maintain compliance. They work closely with regulatory bodies and internal teams to prevent violations and ensure consistent quality in products or services.
What are the key skills and qualifications needed to thrive in quality compliance?
To thrive as a Quality Compliance professional, you need a solid understanding of regulatory standards, auditing processes, and quality management systems, often supported by a bachelor’s degree in a relevant field. Familiarity with compliance software, audit management tools, and certifications such as ISO 9001 or Six Sigma is highly beneficial. Strong attention to detail, problem-solving abilities, and effective communication are vital soft skills for ensuring standards are met and issues are addressed. These competencies are crucial for maintaining organizational integrity, passing audits, and consistently meeting industry-specific regulations.
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Cities with the most Quality Compliance job openings:
What are the most commonly searched types of Quality Compliance jobs?
The most popular types of Quality Compliance jobs are:
What states have the most Quality Compliance jobs?
States with the most job openings for Quality Compliance jobs include:
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Full-time
Re-posted 24 days ago
Job description
We're seeking a Senior Director, Quality Compliance reporting to the VP, Head of Quality, who will be responsible for providing strategic leadership and oversight of the organization's global quality compliance programs, ensuring alignment with regulatory requirements and industry best practices. This role leads key quality systems including supplier oversight, product complaints, and inspection readiness, and partners cross-functionally to drive a proactive, risk-based quality culture that supports development through commercialization.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities (including, but not limited to):
- Develop and implement a comprehensive, risk-based quality compliance strategy aligned with global regulatory expectations (FDA, EMA, MHRA, ICH).
- Provide executive oversight of core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.
- Serve as a senior quality advisor to executive leadership on compliance risks, trends, and mitigation strategies.
- Establish and maintain a robust global supplier quality management program for CMOs, CROs, and critical vendors.
- Oversee qualification, auditing, performance monitoring, and ongoing compliance of external partners.
- Lead development and negotiation of quality agreements to clearly define roles, responsibilities, and compliance expectations.
- Drive vendor performance management through KPIs, risk assessments, and governance forums.
- Provide strategic oversight of the global product quality complaint program, ensuring timely investigation, trending, and closure.
- Ensure compliance with regulatory reporting requirements, including Field Alert Reports (FARs), Biological Product Deviation Reports (BPDRs), and other post-market obligations.
- Drive continuous improvement in complaint handling processes, including root cause analysis and CAPA effectiveness.
- Partner with manufacturing, supply chain, and regulatory teams to mitigate product quality risks and prevent recurrence.
- Lead global inspection readiness strategy, ensuring a continuous state of readiness across all GxP areas.
- Serve as inspection lead and primary point of contact for regulatory agency inspections (FDA, EMA, MHRA, and other health authorities).
- Oversee inspection preparation, execution, and response, including management of commitments, CAPAs, and remediation activities.
- Conduct internal audits and mock inspections to proactively identify and mitigate compliance risks.
- Oversee key quality systems including deviations, CAPAs, change control, and quality metrics.
- Drive harmonization and optimization of QMS processes and digital platforms (e.g., Veeva, TrackWise).
- Establish and monitor quality KPIs to assess system effectiveness and inform executive decision-making.
- Champion a culture of quality, accountability, and continuous improvement across the organization.
- Strategic thinking and enterprise mindset
- Executive communication and influence
- Risk-based decision making
- Change leadership and quality culture transformation
- Operational excellence and continuous improvement
- Lead, develop, and mentor high-performing quality teams across multiple regions.
- Collaborate with CMC, Regulatory Affairs, Clinical, Pharmacovigilance, and Supply Chain to ensure integrated quality oversight.
- Influence and align stakeholders at all levels to drive compliance and business objectives.
Standout Skills for Impact:
- Spearhead quality compliance strategy and governance
- Owns and governs enterprise-wide supplier & external partner oversight
- Drives uncompromising excellence with a patient-first mindset
- Leads collaborative resolution of complex, cross-functional challenges
Qualifications and Experience:
- Advanced degree in a scientific discipline (MS, PhD, or equivalent preferred).
- 12+ years of experience in Quality Assurance/Compliance within the pharmaceutical or biotechnology industry.
- Demonstrated leadership experience in GMP, GCP, and/or GLP environments across development and commercial stages.
- Extensive experience with regulatory inspections and health authority interactions.
- Proven expertise in supplier quality management, product complaints, and inspection readiness.
- Strong knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH).
- Experience with electronic Quality Management Systems (e.g., Veeva, TrackWise)
- Up to 30% travel required.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$250,000-$273,000 USD
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.
About Kiniksa Pharmaceuticals
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
201 - 500 Employees
Headquarters location
Lexington, MA, US
Year founded
2015