Who We Are: Ollin is a biotechnology company developing differentiated, impactful therapeutics for the treatment of serious, common ophthalmic diseases. Our approach is to identify, acquire and develop these therapeutic programs with the highest levels of quality, scientific rigor, and transparency. We are targeting biologies that we believe will make meaningful improvements to patient care and treatment outcomes, and we will prospectively utilize the latest technologies in ophthalmic imaging and data sciences to inform our drug development activities. We are building out our Quality Assurance team to support our Phase 3 programs of OLN324 in neovascular age-related macular degeneration (NAMD) and diabetic macular edema (DME), as well as support work on our earlier stage program, OLN102, in thyroid eye disease and Graves’ disease. Working With Us: As an early employee in this rapidly growing organization, you will help build an ophthalmology-focused, clinical-stage biotechnology company as part of a highly experienced team. You will have opportunities to take on various roles and responsibilities in an environment that supports and celebrates your professional growth. This role is remote based in the continental US. Employees will be expected to attend in-person workplace gatherings at a common location once per quarter as the company grows. This position will require travel up to 10-20% for audits, person in plant, external meetings, and site-facing activities, etc. Key Responsibilities: Provide quality direction and oversight of Contract Service Providers’ (CSPs) manufacturing, testing, and packaging activities, ensuring compliance with cGMP, regulatory requirements and Ollin quality standards. Own batch record review and disposition of all clinical products produced at CSPs. Review and approve CSP’s master batch records, executed batch records, deviations, change controls, test methods, specifications, protocols, and reports. Lead and support investigations into manufacturing, packaging, and testing discrepancies, deviations, and non-conformities, and out-of-specifications, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPAs). Assess the impact of proposed changes on product quality requirements. Assist with the management of the CSP’s quality oversight including external audits, risk assessment, and CSP remediation. May assist in drafting Quality Agreements. Collect and present quality metrics related to Ollin and CSP quality oversight activities. Collaborate cross-functionally with CMC, Supply Chain, Regulatory Affairs, Clinical Operations, and other departments to facilitate effective communication and resolution of quality-related issues. Identify opportunities for process improvements and efficiencies within QA Operations function, driving continuous improvement. Author and revise SOPs where appropriate. Report and escalate significant quality observations and risks to Vice President, Head of Quality. Coordinate and assist in mock and regulatory inspections at Ollin or CSP as needed. Provide GMP training where appropriate. Qualifications: BA/BS degree with a minimum of 12 years’ experience in the pharmaceutical industry (large molecules preferred), including at least 8 years in a Quality Assurance operations role. Thorough knowledge and understanding of cGMP and relevant EU and US regulations, legislation, and pharmaceutical manufacturing industry standards for pharmaceutical manufacturing. Superior written and oral communication skills, and a demonstrated ability to contribute successfully in a multi-disciplinary team environment. Demonstrated ability to successfully work with and influence CSPs while maintaining a collaborative working relationship. Working knowledge of health authority inspections and inspection readiness activities. Experience coordinating and conducting audits of GMP CSPs. Proven proficiency in MS Word, Excel, Power Point, and Adobe Acrobat. Proven ability to work independently and in a team setting is essential. High level of autonomy and motivation. The position will be based in in United States reporting to VP, Head of Quality. We are committed to ensuring all employees, current and future, receive fair and equitable pay. Base pay is one component of the total compensation package. It is determined within a range according to role, level, and location, which gives room to grow as you gain experience and allows for differentiation based on performance. Base Pay Range: $185,000 to $270,000 annually. This is our good faith estimate of the range we reasonably expect to pay for a new hire, as of the date of posting, and it may be modified in the future. The final base pay within the range will be determined by work location and additional factors, including job-related skills, experience, relevant education or training, and market demand for your expertise. Ollin Biosciences, Inc. is an equal opportunity employer. We value diversity and do not discriminate on the basis of race (including hair texture and protective hairstyles), religion (including religious dress and grooming practices), color, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender, gender identity, gender expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, reproductive health decision-making, military or veteran status, or any other characteristic protected by federal, state, or local law. We are committed to creating an inclusive environment for all employees. Ollin Biosciences, Inc. does not accept unsolicited resumes from any agency that we have not directly engaged for a specific role. Our managers and employees will not accept resumes sent directly from any agency or third party. Unsolicited resumes sent to Ollin Biosciences, Inc. from recruiters do not constitute any type of relationship between the recruiter or recruiting agency and Ollin Biosciences, Inc. and do not obligate Ollin Biosciences, Inc. to pay fees should we hire from those resumes.