Americas Associate Program Manager, GMP - Intertek Testing Services NA Inc
Lake Forest, CA 92609
About the Job
Intertek, a leading provider of quality and safety solutions to many of the world's top-recognized brands and companies, is actively seeking a GMP Associate Program Manager (APM) to join our Business Assuranceteam. This is a fantastic opportunity to grow a versatile career in auditing and business assurance.
Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace.
What are we looking for?
The GMP APM is responsible for the role and function of the APM is to provide resource management, technical leadership and overall support to the GMP areas which are part of the medical program.
Salary & Benefits Information
Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications, and other job-related reasons.
In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.
What you'll do:
Program Support:
- At the direction of the Program Manage/Director (PM), the APM provides the necessary support needed to maintain and improve the GMP program. This includes but is not limited to; process improvements, procedure development/revisions, veto/technical reviews, approvals etc.
- Participates in industry conferences as attendee and/or speaker
- Assists with program development to implement new/revised standards and/or audit programs by developing/revising processes, performing training, liaising with accreditors, RAs, major clients, etc.
- Provides the necessary leadership and support for the resolution of internal corrective actions.
- Provides input to monthly and annual KPI's and reporting.
Resources development:
- Works with the PM to recruit and develop full-time and contract audit staff.
- Evaluates and approves competencies of new auditors, for NA managed accredited/authorized programs. Manages the approval of competencies for non-NA managed programs.
- Manages the onboarding of new team members, including Identifying training needs.
Client Satisfaction:
- In conjunction with the PM, develops and sustains positive, effective relationships with "major" sector clients through onsite auditing and ongoing communications.
- Performs NPS calls, close out/resolve client issue, etc.
- Provides support for handling of disputes. Provides the necessary leadership and support for the resolution of client-related complaints and corrective actions.
- Provides technical leadership and support to both new and existing client.
Auditor Management:
- Provides guidance and ongoing support for the medical audit team.
- Conducts annual performance reviews in consultation with PM
- Conduct witness audits of staff
- Utilizes data and trends to develop improvement plans for auditors. Maintains A/B/C rankings. Implements auditor scorecards.
- Maintains auditor competence records, including managing/performing annual update of all necessary documents/records.
- Manages/hosts the monthly auditor development meetings with scheduling and other interested parties.
- In conjunction with the PM, leads and delivers training sessions for the program, including periodic webinars, help to develop and mentor new tutors for training program.
Conduct Audits: Scheduling of audits should be consistent with witness and mentoring needs, in all cases priority should be given to team assignment. Target 5-8 days per month (Varies based on Program needs. This can be an averaged over the period.
This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.
Minimum Requirements & Qualifications:
- 4 year college/university degree in a science or technical field (biology or microbiology; chemistry or biochemistry; computer and software technology; electrical, electronic, mechanical or bioengineering; human physiology; medicine; pharmacy; physics or biophysics) or equivalent combination of relevant education and work experience.
- A minimum of 4+ years of full-time work experience in a dietary supplement, pharmaceutical, and/or cosmetic or related industry (design, development, testing, quality assurance/quality control).
- 3rd party auditing industry management systems experience.
- Working knowledge of relevant GMP and regulatory requirements for dietary supplement, pharmaceutical, and/or cosmetics
- Strong communication and interpersonal skills.
- Sound judgment, organizational, and analytical skills.
- Excellent computer and writing skills.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to exercise effective time management skills in completion of assignments.
- Must be willing and able to travel extensively. Primarily domestic travel, some international travel may be needed.
Preferred Requirements & Qualifications:
- Experience implementing/auditing to dietary supplement, pharmaceutical, and/or cosmetic regulatory requirements.
- Specific experience/training on processes used in the relevant industry's manufacturing
- Training/experience in quality tools (Kaizen, lean manufacturing, etc.).
- Working experience in a wide range of dietary supplement, pharmaceutical, medical device and/or cosmetics organizations.
Physical Requirements:
- Ascend or descend ladders, stairs, ramps, and the like, using feet and legs and/or hands and arms. Body agility is emphasized.
Stand, for sustained periods of time. - Walk, moving on foot to accomplish tasks and to move from one work location to another.
- Communicate well, thru spoken word, conveying detailed accurate information & instructions to others.
- Hear well, perceiving sounds with or without correction, including the ability to receive information thru oral communications.
- Exert up to 10 pounds of force occasionally and/or negligible amounts of force frequently to lift, carry, push, pull or otherwise move objects.
- Have close visual acuity to perform an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devises.
Why work at Intertek?
Intertek is a world leader in the $250 billion Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. At Intertek, we exercise our spirit of innovation, the passion of our people and our unmatched customer commitment to realize our purpose of making the world an ever better, safer, and more sustainable place for all. Learn more about Our History and What We Do .
Intertek: Total Quality. Assured.
Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers' expectations, while engaging with our employees to be 10X in their performance and professional growth.
Intertek is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.
We Value Diversity
Intertek's network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.
For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email hr.eeo@intertek.com or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.
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* Intertek does not accept unsolicited approaches from agencies and will not pay a fee for any placement resulting from the receipt of an unsolicited resume.
The base wage or salary range for this position is $125,000-$150000. Individual compensation packages are based on a variety of factors unique to each candidate including skill set, experience, qualifications and other job-related reasons. Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection and Certification (ATIC) solutions for our customers' operations and supply chains. Working at Intertek means joining a global network of state-of-the-art facilities and passionate people who deliver superior customer service with a purpose of bringing quality, safety, and sustainability to life.