Care Access - Digital Quality & GxP Manager

Remote - USA$208k - $208k2w ago

Remote Mid NA Clinical Research Software Quality Control Manager

Requirements

• Demonstrated leadership experience in implementing compliance programs within the software industry. Project management experience preferred. • Experience with Good Clinical Practice is required • Demonstrated experience with SaaS application and agile product development methodology. • Excellent communication and interpersonal skills • Strong analytical skills with the ability to effectively define business issues and recommendations • High attention to detail and organizational skills • Technical proficiency and understanding of data management in healthcare or clinical trial spaces • Highly detail-oriented with strong time management skills to manage multiple deadlines • Ability to work with minimal supervision and manage multiple priorities in a fast-paced environment • Certifications/Licenses, Education, and Experience • Certifications in GxP quality, computer systems validation processes or quality systems management preferred. • 3+ years of experience implementing GxP standards and advising on matters of quality compliance at a SaaS company, including GxP systems validation • How We Work Together • Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment. • Location • Travel: This is a remote position with travel requirements up to 40%. Occasional planned travel may be required as part of the role. • Travel • Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. • Physical demands associated with this position Include • The expected pay range for this role is $110,000 - $140,000 USD per year for full time team members.

Benefits

• Paid Time Off (PTO) and Company Paid Holidays • 100% Employer paid medical, dental, and vision insurance plan options • Health Savings Account and Flexible Spending Accounts • Bi-weekly HSA employer contribution • Company paid Short-Term Disability and Long-Term Disability • 401(k) Retirement Plan, with Company Match • Mandatory Employer Disclosures • Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. • Notice to Illinois applicants: • Notice to Connecticut applicants: • Notice to Arizona, Georgia, Indiana, and North Dakota applicants: • Notice to Massachusetts applicants: • Notice to Rhode Island applicants: • Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100. • Diversity & Inclusion • We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.