Quality Manager/Senior Quality Manager

The Quality Manager/Senior Quality Manager is responsible for all aspects of quality assurance for drug products manufactured at contract manufacturing organizations. This role also administers quality programs, including batch release, change control, NCRs and CAPAs / SCARs, and ensuring compliance with US, Canadian, and EU regulations. The focus of this position will be on oversight of drug product manufacturing CMOs. This position reports to the Vice President, Quality. Responsibilities Ensure the implementation and maintenance of Quality Systems and documentation, including the compliance status of change controls, non-conformances, CAPAs, and SCARs internally and with suppliers Serve as a Subject Matter Expert for aseptic processing and visual inspection. Provides GMP advice at all levels of the company, including support to the development of processes and procedures that are compliant with international QMS requirements and product development/design controls Interacts with suppliers including performing audits as part of the supplier management process Manage Inspection Readiness activities for Quality Systems Support the overall process to Identify/develop, measure and monitor metrics which are key performance indicators and provides these metrics reports to senior management Disposition commercial and clinical lots through batch documentation review Required Expertise Competencies BS degree or postgraduate qualification in nursing, life sciences or medical sciences, or equivalent work experience Minimum of seven years of experience in Quality Assurance in the pharmaceutical product industry, with parenteral product experience a plus Experience in validation and quality management (deviations, NCR, Change control etc.) of aseptic processes a plus Required Power Competencies Teamwork & Leadership: Functional influencer; builds effective partnerships and works collaboratively with others to meet shared objectives; knowledge of company structure; deliberately includes and inspires colleagues and team members. Execution: Consistently directs, drives and holds others accountable for cross-functional results; identifies ambiguity and a path forward; removes obstacles to facilitate work. Solution Maker: Dissects functional work/process issues to discover opportunities for improvement; leverages resources to deliver function-level solutions/improvements; begins building internal and external networks; demonstrates courage to ask questions, try new things, and provide feedback. Continuous Improvement: Creates new ways for self and team to be effective; proactively leverages resources where appropriate; early adopter and implementer of technology and student of industry. Awareness: Leverages awareness and recognition of the strengths and limitations of others; resolves ambiguity and helps others reframe questions to optimize ideas and solutions. You excel at working both individually and in a team environment You are passionate about your work and display a high level of emotional intelligence in your decision making You understand, appreciate, and thrive in a growing organization and have the desire to learn new skills to contribute to company success You can manage various projects, solve problems, and deliver on commitments You can understand strategy, transition to execution, and effectively collaborate cross functionally You have excellent communication and collaborative skills You strive for excellence and expect the same from your team and colleagues Expectations This position is hybrid with a minimum of two days per week in Burlington, MA office, between Tuesday and Thursday. Additional time in the office could be required as circumstances dictate. EEO Statement scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. It is the Company’s policy and intent to provide equal opportunity in employment, development and advancement without regard to a race, color, religious creed, sex, pregnancy, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, ancestry, military service or veteran status, marital status or any other category protected under applicable federal, state or local law. #J-18808-Ljbffr