VP, Quality and Regulatory

Job Description

Job Description

About Discovery Life Sciences:

Discovery Life Sciences (Discovery) is a trusted provider of genomic, bioanalytic and biospecimen services to thousands of customers across the United States and around the world. Leading biopharma, diagnostic and academic institutions trust us to quickly deliver high-quality biospecimens and reliable, reproducible biomarker data, to support discovery, translational, and clinical research.

Position Summary:

The Vice President of Quality Assurance is accountable for all aspects of the Quality Management System (QMS) to support compliant operations, foster continuous quality improvement, and to maximize customer satisfaction. This position will support the building of a Quality-minded culture across the organization and provide strong leadership and expertise in establishing, implementing, and maintaining Quality standards throughout the Company’s complete value chain.

Why Join Us:

At Discovery, you will have the opportunity to lead a talented quality team and make a significant impact on the growth and success of a pioneering company in the biotech and life sciences industry. We offer a collaborative and innovative work environment, competitive compensation, and the chance to work on groundbreaking projects that contribute to improving patient outcomes globally.

Must-Have Qualifications (Education, Skills, Experience):

• Bachelor’s Degree in life sciences, natural science, business, or similar field; Masters’ degree or higher preferred (business, healthcare administration, public health)
• 10+ years’ Quality Assurance experience in pharmaceuticals/biologics/diagnostics industry with increasing management responsibility
• 5+ years of experience in a Quality leadership position
• Expert knowledge and demonstrated previous management of Quality systems, CLIA, CAP, GC(L)P, GMP, ISO, FDA, EU and/or ICH regulations related to medical devices (especially IVDR) as well as clinical trials and performance evaluation studies, including inspections/audits from the responsible agencies
• Demonstrated expertise in root cause investigation and experience leading high-level compliance investigations
• Strong background and demonstrated effectiveness in quality assurance operations and compliance for research and regulated products and services
• Demonstrated leadership, interpersonal, communication and motivation skills with evidence of building, growing and transforming an organization is required
• Proficient in the use and development of electronic Quality systems
• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence

Key Responsibilities:

• Responsible for all aspects of Quality within the assigned businesses, geographies, or otherwise as defined by the Company
• Support the Company in the implementation and maintenance of the requirements from quality management systems and accreditation/ certification and regulatory bodies and authorities and support the communication with all such bodies and authorities
• Coordinate and monitor all measures for quality assurance in coordination with the business and others within the Global Quality Department
• Act as a key contact with customers, auditors, and ensure the execution of correction actions and ongoing compliance with customer specifications; provide consultative support and direct contact when needed in connection with other customer calls/meetings requiring Quality expertise
• Accountable for defining, measuring, and documenting critical Quality Metrics and sharing metrics with the laboratory services leadership team
• Promote an understanding of the regulatory landscape and industry trends and works in partnership with management to develop strategy plans that support the direction of the business.
• Manages daily activities of Quality staff members, monitoring their productivity, performance and effectiveness driving their personal and professional development
• Participate as a member of the Quality leadership team to determine strategy and implement plans to provide exceptional Quality support to the Company
• Partner with other functional areas, such as IT, Legal, Compliance, and Privacy, to recommend, implement and/or integrate improvement opportunities within the Company’s platforms and processes
• Ensure compliance with all applicable laws and regulations

Compensation and Benefits:

Discovery Life Sciences is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's qualifications, skills, and experience.

Your annual salary is only one part of your total compensation package. Other benefits:

• Competitive salary and benefits package options including free medical, dental, vision, life, and disability which start on your first day of employment!
• 401(k) match program which starts on your first day of employment
• Time away from work (Generous vacation and paid time off, your BIRTHDAY, paid parental leave, paid family leave, etc.)
• Professional development opportunities and reimbursement for relevant certifications.
• Collaborative and inclusive work environment that values diversity
• Team-building activities and social events
• Employee Referral Program and Colleague Recognition Program

Location and work hours:

• Must be located near or willing to relocate to Pennsylvania, Alabama, or Germany.
• Discovery encourages executives to have an onsite presence for meetings and collaboration as often as possible. Executives located near company office locations will have the flexibility to work remotely as needed.

We are actively seeking motivated, dedicated individuals like you to join our thriving organization. As a leader in our industry, we offer unparalleled opportunities for professional growth and success.