Associate director, quality assurance job description

Scholar Rock is a Phase 3, clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.

Our most advanced investigational product candidate, apitegromab (SRK-015), a selective inhibitor of the activation of the growth factor myostatin in skeletal muscle, is in development for the treatment of spinal muscular atrophy, or SMA. Following positive results from the TOPAZ Phase 2 trial in patients with Type 2 and Type 3 SMA, we are now advancing apitegromab development through SAPPHIRE, an ongoing, randomized, double-blind, placebo-controlled, phase 3 clinical trial. In addition, we are conducting our DRAGON Phase 1 proof-of-concept trial for SRK-181, a selective inhibitor of latent TGFβ1 activation, in patients with locally advanced and metastatic solid tumors.

By combining our deep structural insights with antibody drug discovery, Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis.
Summary of Position:

Playing a critical role within Scholar Rock, the Associate Director, GCP Quality Assurance will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. The Associate Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as varied vendors supporting Scholar Rock sponsored Clinical Studies.

This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems at Scholar Rock as we grow and mature organizationally. This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities.
Position ResponsibilitiesAct as GCP QA Program Lead while working with internal stakeholders to ensure overall study compliance from risk-based principles. Provide expert GCP consultation within the Scholar Rock organization.Work with internal and external Study Team members and develop and execute strategic plans to identify, mitigate, monitor and report site, study and program level compliance risks.Assist in resolving compliance issues at clinical sites, clinical vendors, and laboratories and provide assessment of the impact of any deficiencies. Escalate issues through the Quality Organization as needed.Coordinate with the Scholar Rock Vendor Audit Manager to ensure successful planning, execution and closure of GCP Vendor audits including CRO, Central and Specialty Laboratories, IxRS/IRT/Randomization vendors, IRB/IECs and other vendors. Manage the Scholar Rock Clinical Investigator (CI) Site Audit program. Coordinate with Study Team members to determine CI sites to be audited per study via risk-based criteria. Coordinate with Study Team members and third-party auditors to ensure CI site audits are appropriately scoped, planned executed and closed.Determine if CI Site audit observations may represent study-wide or program-wide risks and ensure Impact/Risk Assessments and Study-wide/Program-wide CAPAs are adequate. Coordinate with Scholar Rock Senior Management, Functional Area Leads, and third-party vendors, on Inspection Preparation activities including mock inspections, gap assessments, resolution and mitigation of identified compliance concerns. Provide key support during and after regulatory inspections. Coordinate with Program Leads, Biostatistics, Data Management, Medical Affairs, Pharmacovigilance to develop/implement Phase appropriate procedures to ensure consistency and quality with respect to Clinical Trial support activities at Scholar Rock.
Candidate RequirementsBachelor's degree in the Life Sciences with 10+ years in pharmaceutical or biotech drug development. Advanced degree preferred.Minimum 5 years of experience in Clinical QA, including both external and internal auditing.Demonstrated experience working with clinical trial teams.Extensive experience with Global Clinical trial conduct, knowledge and understanding of ICH E6 (R2) GCP Guideline, FDA Regulations and EU Requirements.Previous experience facilitating and/or supporting Regulatory Authority Inspections.Direct experience in development and oversight of Quality Management Systems.Ability to evaluate and reorganize priorities quickly in a dynamic matrixed setting. Excellent interpersonal skills, personal integrity, professional manner and ability to gain respect and develop good working relationship with cross functional personnel at all levels.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Support the company's short- and long-term goals for maintaining Quality Systems and Compliance. Provide direct oversight for the evaluation, implementation, execution and follow-up on quality systems in support of GMP compliance and release of finished product. Oversee quality assurance of the manufacturing and packaging processes and procedures, the final review of investigations, and appropriate implementation of corrective actions to prevent recurrence.

Provide input into the overall decision-making process pertaining to the quality problems internal and external that can have far reaching results in terms of rejected batches, stock withdrawals, quarantined goods, revised production and marketing schedules and added manufacturing costs.
Responsibilities

Health Benefits begin day 1 of employment:
Health InsuranceDental InsuranceVision InsurancePrescription CoverageFlexible Spending Accounts
We also offer:
Same Day PayVacation-3 weeks, Paid Holidays, Sick Pay 401(k) with a company contribution that is 100% vested Disability and Life insurance Dependent Spouse and Child Life InsuranceEmployee Assistance ProgramTuition ReimbursementAuto and home insurance programs Legal Insurance

Key activities of the Job:
Provides daily oversight of the MQA and Aseptic Mentor teams responsible for supporting all production/processing areas. Develop, and monitor appropriate KPI's for batch documentation review, Right Frist Time (RTF) and support of 28-day batch release cycle.Responsible for department resource planning, talent development, and budget administration with regards to MQA and Aseptic Mentor personnel, equipment, and facilities.Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation. Interacts with the Vigilance and Medical Affairs Department as needed.Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.Provides QA review and approval of Investigations, CAPAs, SOPs, Material Change Controls, CNs, DCRs, training documentation, and protocols/reports. Ensures completeness, accuracy and compliance of all documentation.Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics / KPIs.Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.Independently and proactively seek new information to assure current status with compliance and regulatory issues through evaluation of available documentation, e.g. other company's 483/Warning Letters, cGMP Trends, new FDA Guidance Documents, PDA, etc.Has authority to make decisions for the PU QA department.
Key skills for success:

Bachelor degree of Science with a minimum of 8 years of progressive challenging QA/QC experience, including 5 years as a manager or above, in pharmaceutical or related regulated industry.Advanced training or experience in cGMP and GLP, legal and ISO requirements.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

The Regeneron Associate Director QA Auditing-GLP is a key position in the Quality Assurance and Auditing group and will provide professional expertise, guidance, and leadership for the GLP Audit Program. This individual will create strategic partnerships and direct risk-based quality auditing activities across Preclinical Development (GLP). This individual applies expertise in Good Laboratory and international regulations and guidelines to the auditing process to independently address a variety of compliance issues associated with drug development. This individual is responsible for ensuring auditors have the education, experience and/or training necessary to be able to identify compliance issues and negotiate resolution in a highly autonomous manner. The individual should have an expert knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development including HIPAA Privacy Rule, and other international and national rules as applicable. Manages the GLP audit function within the Quality Assurance and Auditing organization.
In this role, a typical day might include the following:

•Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines.

•Responsible for departmental and/or project related results, costs, methods, staffing, managerial planning and integration

•Applies expert-level understanding of discipline/specialization and advanced interpersonal and communication skills.

•Manages resources & staff to accomplish the annual audit schedules.

•Conduct audits as needed.

•Responsible for managing and developing direct reports, providing leadership, guidance, and supervision as required.

•Assess and prioritize both internal and external audit needs.

•Liase with Quality Assurance and cross functional teams to facilitate the adequate closure of audits.

•Represent QAA on teams, compliance projects and initiatives both within and across functional areas of Preclinical and Global Development to ensure compliance with related regulations and internal procedures.

•Escalates compliance risks to Executive level management as needed.

•Assist in the selection, training and overseeing the onboarding of contract auditors, as needed.

•Drafts and issues periodic area metrics reports to management, cross functional groups and leadership teams as requested.

•Delegate, as necessary, tasks and duties to other functional staff.

•May assist in the conduct and act as a subject matter expert in regulatory facility inspections.

•Ensure succession planning and business continuity for the GLP audit function.

This role might be for you if:

Bachelor's degree ( Master's degree preferred) with 12+ years of relevant industry experience 10+ years' experience working in GLP auditing and 5+ years prior supervisory/leadership experience required. Excellent communication skills and ability to work with people in all levels of the organization and externally. Demonstrated skills in taking initiative and working independently Experience with FDA or other Regulatory Inspections of Sponsors or CROs. Demonstrated experience in driving Quality into the GLP Operations processes Self-motivated with the ability to work effectively in a dynamic environment with ambiguity Strong leadership with demonstrated ability to interface with senior leaders Good problem solving, written and verbal communication skills Ability to effectively manage multiple priorities with a sense of urgency Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations Attention to detail and accuracy of work

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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