- Responsible for final product Quality release/rejection and related processes.
- Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA.
- Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply.
- Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & procedures
- Lead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc
- Provide oversight of QC equipment program, which includes qualification, calibration, PM, etc
- Review and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operations
- Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP).
- Responsible for QA representation in Design Control Process for medical device products and combination products.
- Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects.
- Manage the performance and development of 3-6 direct reports.
- Support supplier and internal audits as necessary.
- Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc.
- Act as company's representative during regulatory agencies and customer inspections.
- Supports the investigation of product and related CAPAs.
- Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department.
- Support Statistical Trending of Manufacturing and Analytical Data.
- Additional duties as assigned
Qualifications - BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required
- Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.
- Commercial drug manufacturing site QA head experience preferred
- Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
- Ability to solve complex problems and take proactive action
- Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
- Maintain professionalism, self-motivation, and enthusiasm.
- Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing.
- Must perform statistical analysis and capable of analyzing data to solve problems
- Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines
- Solid knowledge of all QC laboratory equipment and manufacturing equipment
- Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
- Experience with internal and external audits.
- Experience reviewing manufacturing and QC validation documents.
- Preferred ASQ CQE and CQA Certifications.
- Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971.
- Demonstrate ability to manage projects and variable workloads.
- Excellent communication and coaching skills (verbal and written).
- Highly organized with a strong attention to detail, clarity, accuracy, and conciseness.
- Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Travel RequirementsUp to 30% travel, both domestic and/or international.
Salary Range
Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees.
The base salary range for this job is from $200,000.00 to $280,000.00 per year
Compensation & BenefitsWe're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including:
- Flexible approach to where and how we work, regionally based
- Competitive compensation package including bonus
- Stock options and RSU awards
- Employee Stock Purchase Plan (ESPP)
- Flexible Vacation Policy
- Generous paid holiday schedule and winter break ADDITIONAL U.S. BENEFITS:
- 401(k) plan with company match
- Medical, dental, and vision plans
- Company-provided Life and Accidental Death & Dismemberment (AD&D) insurance
- Company-provided short and long-term disability benefits
- Unique offerings of pet, legal, and supplemental life insurance
- Flexible spending accounts for medical and dependent care
- Accident and Hospital Indemnity insurance
- Employee Assistance Program (EAP)
- Mental Health on-line digital resource
- Well-being reimbursement
- Paid leave benefits for new parents
- Paid time off to volunteer
- On-site, no-cost fitness center at our U.S. headquarters
Additional InformationInsmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
-
Sr Director Quality Assurance Operations
1 week ago
Insmed Incorporated Bridgewater, United StatesCompany Description · Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicate ...
-
Manager, Quality Assurance Operations
5 days ago
ElevateBio Waltham, United StatesElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Procurement Clerk
2 weeks ago
NovaWorks Plymouth, United StatesWe are looking for motivated employees for over 500 different professions. And that's all over Germany. Whether experienced professionals or career starters - we offer numerous entry and further training opportunities. · At the earliest possible date, we are looking for you as a ...
-
BlueWave Ventures Plymouth, United StatesTQ stands for Technology in Quality. This is what each of our 2,200 employees stands for. · As one of the largest electronics specialists in Germany, we develop and produce customized and innovative solutions for renowned clients from various industries. In addition, TQ offers re ...
-
Manager, Quality Assurance Operations
3 weeks ago
ElevateBio Watertown, United States Full timeElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicine ...
-
Certified Welding Inspector
3 weeks ago
RCG Moody International Limited c/- Intertek Plymouth, United StatesCertified Welding Inspector · PSI is looking for a Certified Welding Inspector to join our Building & Construction team in Plymouth, MI. · Intertek-PSI is a leading US based provider of assurance, testing, inspection, and consulting solutions in civil and commercial construction ...
-
Sr. Specialist
1 week ago
Acme Smoked Fish Corp Brockton, United StatesThe Sr. Specialist - Quality Assurance & Food Safety is responsible for leading all aspects of Acme Smoked Fish Corporation's food safety and quality programs. This role ensures that all products meet food safety, customer, federal and state compliance. · What You Will Do At Acme ...
-
CNC Lathe Machinist Setup/Operator
6 days ago
J&E Companies Plymouth, United StatesShift: Mon-Thurs. 5:30am - 4:00pm · Lathe Machinist Description: · The CNC Turning (lathe) Machinist is responsible for setting-up, programming, edit and running computer numeric controlled production equipment to produce precision machined components. Must have 3+ years of hands ...
-
Ski Lift Mechanic
3 weeks ago
Tenney Resort & Recreation LLC Plymouth, United StatesResponsibilities · Responsible for maintenance activities required to assure safe and reliable operation of the area's lift system and associated equipment. · Utilize safety guidelines to conduct daily, weekly and monthly inspections of assigned lift equipment. · Must become p ...
-
Allina Health Plymouth, United States Full timeDescription · : Principle Responsibilities · Supervises the daily operations of the department.Checks daily work assignment to assure preparedness.Provides clinical and technical assistance to technologists on related equipment and procedures.Manages daily staffing and overtim ...
-
Sterile Processing Technician
2 weeks ago
TalentBurst, an Inc 5000 company Plymouth, United StatesCertified Sterile Processing Technician · 13 Weeks · 40 Hours/week · 8H Evening · 03:00 PM - 11:30 PM · Description: · MUST BE NATIONALLY CERTIFIED -HSPA cert · Duties/Responsibilities: Primary responsibility is infection control. Maintain sterile technique. Perform all duties a ...
-
2024 Summer Internship
3 weeks ago
RCG Moody International Limited c/- Intertek Plymouth, United States InternshipSHIP2024 Summer Internship - Construction Technician · Professional Service Industries, Inc. (Intertek-PSI) is looking for a 2024 Summer Internship - Construction Technicians to join our Building & Construction team in Plymouth, MI. · Intertek-PSI is a leading US based provider of a ...
-
ESG Programs and Reporting Manager
1 day ago
Amneal Pharmaceuticals Bridgewater, United States Full timeDescription: · Reporting to the Director of ESG Programs and Reporting and sitting on the global ESG Team: this Manager will support the implementation of the company's ESG strategies. This Manager will work across all three workstreams: preparation of sustainability data for re ...
-
Registered Nurse, Clinic
2 weeks ago
223 Aurora Medical Group, Inc. Plymouth, United States Part timeDepartment: · 02190 AMG Plymouth Kiley Way - Immediate Care Status: · Part time Benefits Eligible: · Yes Hou rs Per Week: · 28 Schedule Details/Additional Information: · Weekend Program Hours include: · Fridays 8-8p. · Saturday and Sundays 745-8pm. · Major Res ...
-
Nurse Practitioner
3 days ago
OI Infusion Plymouth, United StatesOI Infusion Services · Nurse Practitioner Job Description · About OI Infusion Services · OI Infusion Services partners with physicians to provide comprehensive infusion therapy services in their offices, ensuring the best standard of care at the point of service to patients. · We ...
-
Quality Supervisor B Shift 6:00 pm
3 weeks ago
Webasto Americas Plymouth, United StatesCompany Description · Webasto Americas, a key region of the Webasto Group, is a global automotive supplier specializing in roof systems and electrification solutions. Headquartered in Auburn Hills, Michigan, Webasto Americas operates with approximately 4,000 employees across the ...
-
Interrad Medical Plymouth, United StatesThe Director of Quality Assurance and Regulatory Affairs position at Interrad Medical will be a key person within the organization who leads and ensures compliance to the quality system at Interrad Medical. This position will provide hands on leadership, tactical implementation, ...
-
Maintenance Technician
2 weeks ago
Engauge Workforce Solutions Plymouth, United StatesMaintenance Technician ($ /hr) · Location: Plymouth, MI · Shifts: 2nd (3 PM - 11 PM) & 3rd (11 PM - 7 AM) · Engauge is seeking an experienced Maintenance Technician to provide maintenance support to the cell/area to achieve optimal levels of productivity, quality, and safety to a ...
-
Quality Engineer
1 week ago
J. Wagner GmbH Plymouth, United StatesWAGNER - Powered by Talents · With more than 2,000 employees at 21 locations worldwide, we are one of the market-leading manufacturers of innovative coating technology. Do-it-yourselfers, craftsmen and industrial customers all over the world trust in our innovative products, reso ...
-
Electrical Engineer
1 day ago
RCG Moody International Limited c/- Intertek Plymouth, United StatesProject Engineer - Safety · Intertek is searching for a Project Engineer to join our Transportation Technologyteam in our Plymouth, Michigan office. This is a fantastic opportunity to grow a versatile career in Transportation Technologies · Our Value Proposition - We Offer: Compe ...
Sr Director Quality Assurance Operations - Bridgewater, United States - Insmed Incorporated
Description
Company Description
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions
Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in BiopharmaTM, Best Workplaces in New YorkTM, and Best Workplaces for MillennialsTM lists.
Overview
Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA and QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers. This is a supervisory position with 3-6 individual direct reports.
Responsibilities
Additional representative responsibilities will include, but not necessarily be limited to, the following: