Program Manager I, Quality Compliance

Job description

Changing lives.

Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare.

Thinking differently is what we do best.

To us, change equals opportunity.

Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

**ESSENTIAL DUTIES AND RESPONSIBILITIES**

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily including their overarching responsibility of overseeing the implementation of the ECMP at the sites, including:

+ Developing and managing the site project plan;
+ Reporting on the sites' progress to the ECMP Project Manager;
+ Being responsible for the site(s) ECMP documentation and schedule;
+ Coordinating collaborative activities across the sites' workstream activities;
+ Other duties as assigned.

**DESIRED MINIMUM QUALIFICATIONS**
The requirements listed below are representative of the knowledge, skill and/or ability required for this position.

Education:

+ Bachelor's degree is required, and engineering, science or closely related technical discipline is preferred.

Skills/Knowledge:

+ 8+ years of experience leading program and project teams (including direct reports) or equivalent education and years of management experience is required.
+ Experience in highly regulated industries required, medical device and/or pharmaceutical preferred, including material remediation experience.
+ Experience in implementing remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR is required
+ Strong analytical skills, exceptional writing and interpersonal relationship skills or a combination of relevant work experience and education is required.
+ Demonstrated organizational, management and communication skills is required.
+ Proven track record of cross-functional collaboration across teams and change management skills is required.
+ Strong communication and presentation skills, with the ability to articulate program status and risks to key stakeholders is required.
+ Knowledge of process design and implementation, change control, auditing, and document management systems required, general knowledge of statistical analysis preferred.

Travel

+ Ability to travel up to 50% if needed based on site needs.

Regular on-site presence at designated facilities within scope of responsibilities.

Salary Pay Range:

$94,300.00 - $129,950.00 USD Salary
Our salary ranges are determined by role, level, and location.

Individual pay is determined by several factors including job-related skills, experience, and relevant education or training **.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation **.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations.

If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) .

If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities.

All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.

No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.

A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition.

Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement.

Please, no phone calls or emails.

Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)

Required Skill Profession

Other General